Reported Reactions

Manufacturers

Device manufacturer, as written on reports

C R Bard Covington -1018233: medical device reports filed with FDA

60,777 reports name it as the manufacturer of the device involved, 2012–2026.

60,777
reports naming it as manufacturer
0.2% of all MAUDE reports
8,290
reports, 12 months to August 2026
7,949 in the 12 months before
85%
classified as malfunction
62.3% across all reports
0.1%
classified as death, as reported
0.9% across all reports

60,777 medical device reports received by FDA give C R Bard Covington -1018233 as the manufacturer of the device involved, 0.2% of the MAUDE database, from March 2012 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

8,290 reports arrived in the 12 months to August 2026, close to the 7,949 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (85%), injury (14.9%) and death (0.1%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

BrandDevice typeReportsLatest 12 monthsClassified as death
Bardex Lubricath Foley CatheterCatheter, coude4,8866530%
Bardex Lubri-Sil I.C. Temperature-Sensing All-Silicone Foley CatheterCatheter, urological (antimicrobial) and accessories4,4228710%
Bardex I.C. Foley CatheterCatheter, urological (antimicrobial) and accessories3,9985620%
Bardex Lubri-Sil I.C. All-Silicone Foley CatheterCatheter, urological (antimicrobial) and accessories3,1116200%
Bardia Foley Catheter Silicone CoatedCatheter, coude2,4121930%
Bardex Foley Catheter Silicone CoatedCatheter, urological1,8583060.1%
Bardex I.C. Temperature Sensing Foley CatheterCatheter, urological (antimicrobial) and accessories1,8453030%
Magic3 Coude Intermittent Catheter with Sure-Grip SleeveCatheter, urological1,490710.1%
Bardex All-Silicone Foley CatheterCatheter, retention type, balloon1,4721960%
PureWick Urine Collection SystemCollector, urine, powered, non indwelling catheter1,4621,1290.1%
Magic3 Intermittent Catheter with Sure-Grip SleeveCatheter, urological1,389220%
Bardex Lubri-Sil All-Silicone Foley CatheterCatheter, retention type, balloon1,3482940.1%
Latex Foley CatheterCatheter, coude1,24770%
PureWick Female External CatheterCollector, urine, powered, non indwelling catheter1,1521140.6%
Bardex I.C. Complete Care Foley TrayCatheter, urological (antimicrobial) and accessories978540%
Magic3 Go Intermittent Urinary CatheterCatheter, straight78990%
Bard DigniShield Stool Management SystemTubes, gastrointestinal (and accessories)649940.7%
Personal Catheter Intermittent CatheterCatheter, urological588120%
Magic3 Go Male Catheter with SureGripCatheter, straight425120%
Magic3 Go Male Coude Catheter with SureGripCatheter, straight412360.2%
Magic3 Intermittent CatheterCatheter, urological403110%
Bardex Lubri-Sil I.C. All-Silicone Temp Sensing Foley CatheterCatheter, urological (antimicrobial) and accessories383570.2%
Sl Foley Swivel Silicone Tricot 25bxHolder, ureteral catheter36700%
Bard InLay Optima Ureteral StentStent, ureteral354440%
Unknown Latex Foley CatheterCatheter, coude3361740%
Bardia Coude Olive Tip Urethral Foley CatheterCatheter, urological299150%
PureWick Flex Female External CatheterCollector, urine, powered, non indwelling catheter2672200%
Unknown Latex Temp-sensing CatheterCatheter, coude263540%
Channel DrainCatheter, irrigation228660%
Closed Wound SuctionApparatus, suction, single patient use, portable, nonpowered220800%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product codeDevice typeReportsShare
MJCCatheter, urological (antimicrobial) and accessories15,91426.2%
KODCatheter, urological10,07116.6%
EZCCatheter, coude9,81116.1%
EZLCatheter, retention type, balloon5,0898.4%
NZUCollector, urine, powered, non indwelling catheter3,8726.4%
EZDCatheter, straight2,2293.7%
KNXCollector, urine, (and accessories) for indwelling catheter1,5932.6%
FADStent, ureteral1,3932.3%
EYJHolder, ureteral catheter9531.6%
GCYApparatus, suction, single patient use, portable, nonpowered9071.5%

Reports by month, five years

06331,265Sep 2021: 569Oct 2021: 543Nov 2021: 585Dec 2021: 7472022Jan 2022: 270Feb 2022: 491Mar 2022: 645Apr 2022: 1,059May 2022: 778Jun 2022: 499Jul 2022: 531Aug 2022: 574Sep 2022: 539Oct 2022: 423Nov 2022: 632Dec 2022: 5902023Jan 2023: 491Feb 2023: 543Mar 2023: 624Apr 2023: 556May 2023: 615Jun 2023: 602Jul 2023: 570Aug 2023: 547Sep 2023: 404Oct 2023: 365Nov 2023: 529Dec 2023: 4622024Jan 2024: 298Feb 2024: 364Mar 2024: 403Apr 2024: 433May 2024: 463Jun 2024: 487Jul 2024: 504Aug 2024: 469Sep 2024: 428Oct 2024: 555Nov 2024: 529Dec 2024: 5912025Jan 2025: 547Feb 2025: 619Mar 2025: 591Apr 2025: 815May 2025: 690Jun 2025: 1,028Jul 2025: 856Aug 2025: 700Sep 2025: 1,265Oct 2025: 891Nov 2025: 687Dec 2025: 7892026Jan 2026: 535Feb 2026: 675Mar 2026: 582Apr 2026: 516May 2026: 600Jun 2026: 628Jul 2026: 644Aug 2026: 478

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.1%38
Injury14.9%9,055
Malfunction85%51,678
Other0%6
Not given0%0

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about C R Bard Covington -1018233 reports

How many FDA device reports name C R Bard Covington -1018233 as manufacturer?

60,777 reports through August 2026, 8,290 of them in the latest 12 months.

Which of its brands appear most often?

Bardex Lubricath Foley Catheter (4,886), Bardex Lubri-Sil I.C. Temperature-Sensing All-Silicone Foley Catheter (4,422), Bardex I.C. Foley Catheter (3,998), Bardex Lubri-Sil I.C. All-Silicone Foley Catheter (3,111) and Bardia Foley Catheter Silicone Coated (2,412).

Which device types does it report on?

catheter, urological (antimicrobial) and accessories (26.2%), catheter, urological (16.6%), catheter, coude (16.1%) and catheter, retention type, balloon (8.4%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.