Reported Reactions

Devices › Anesthesia conduction kit

Device brand name · Anesthesia conduction kit

Portex Spinal Anesthesia Trays: medical device reports filed with FDA

323 reports name it, 2010–2019. Manufacturer given most often on reports: Smiths Medical Asd. Product code CAZ.

323
device reports naming the brand
0% of all MAUDE reports · about 20 a year
0
reports, 12 months to August 2026
0 in the 12 months before
23.8%
classified as malfunction
69% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 323 reports that name the brand "Portex Spinal Anesthesia Trays" (anesthesia conduction kit), received between January 2010 and April 2019; the manufacturer given most often on reports is Smiths Medical Asd. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none in 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 injury (76.2%) and malfunction (23.8%); across all anesthesia conduction kit reports (product code CAZ) death is recorded in 0.1% and malfunction in 69%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are defective device (14.2%), output problem (3.7%) and failure to deliver (3.1%). The patient problems coded most often are awareness during anesthesia, therapy/non-surgical treatment, additional and numbness. 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."

Reports by month, five years

No report naming Portex Spinal Anesthesia Trays was received in the five years to August 2026; the latest was received in April 2019.

By year received

039772010: 1020102011: 1520112012: 1120122013: 5720132014: 5920142015: 7720152016: 720162017: 520172018: 7420182019: 82019

Event type and report source

Event type, as classified on the report

Death0%0
Injury76.2%246
Malfunction23.8%77
Other0%0
Not given0%0

Who filed the report

Manufacturer report99.4%321
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0.6%2

Grey bar: all 5,156 reports carrying product code CAZ. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Defective devicethe device was defective4614.2%2.8%
Output problem123.7%0.5%
Failure to deliverthe device did not deliver the dose or item103.1%0.3%
Failure to infuse30.9%0.2%
Insufficient device problem information30.9%1%
Improper or incorrect procedure or method20.6%0.4%
Insufficient flow or under infusion20.6%0.1%
Defective component10.3%1%
Device operates differently than expectedthe device behaved unexpectedly10.3%1.2%
Fracturea broken bone10.3%1.7%
Improper device output10.3%0%
Material frayed10.3%0.5%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Awareness during anesthesia19861.3%
Therapy/non-surgical treatment, additional8827.2%
Numbnessnumbness103.1%
Weakness103.1%
Painpain, site not specified30.9%
Underdoseless than the intended dose30.9%
Aneurysm10.3%
Blood pressure, decreased10.3%
Foreign body in patientpart of a device left in the patient10.3%
Meningitis10.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasurePortex Spinal Anesthesia TraysProduct code CAZAll MAUDE reports
Reports3235,15626,136,888
Share of that pool—6.3%0%
Classified as death, per 1,000 reports019
Classified as injury76.2%26.3%36.2%
Classified as malfunction23.8%69%62.3%
Filed by the manufacturer99.4%84.6%94.9%

Shares are of reports, not 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."

Other brands with product code CAZ

BrandReportsLatest 12 monthsClassified as death
Epidural Catheterization Kit1,21730%
Epidural Catheterization Set545290%
Perifix760420%
Arrow Epidural Anesthesia Kit154120%
Arrow Epidural Catheterization Kit202150%
Custom Pak1,26200%
Arrow830653.4%
Portex97080.6%
Arrow Epidural Catheterization Set187800%
Pencan190170%
B Braun270123%
Design Options174110%
Bd19101%
Avanos170381.2%
Braun365240.5%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Portex Spinal Anesthesia Trays reports

How many FDA reports name Portex Spinal Anesthesia Trays?

323 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

injury (76.2%) and malfunction (23.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

defective device (14.2%), output problem (3.7%), failure to deliver (3.1%), failure to infuse (0.9%) and insufficient device problem information (0.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Portex Spinal Anesthesia Trays was at fault?

No. 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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.