Device brand name · Spinal anesthesia kit
Pencan: medical device reports filed with FDA
190 reports name it, 2001–2026. Manufacturer given most often on reports: B Braun Medical.
- 190
- device reports naming the brand
- 0% of all MAUDE reports · about 7 a year
- 17
- reports, 12 months to August 2026
- 25 in the 12 months before
- 55.8%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
190 medical device reports received by FDA name the brand "Pencan" (spinal anesthesia kit); the manufacturer given most often on reports is B Braun Medical; received from February 2001 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
17 reports arrived in the 12 months to August 2026, down 32% from 25 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 malfunction (55.8%), injury (42.6%) and other (1.6%). Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (54.7%), contamination /decontamination problem (2.6%) and device operates differently than expected (2.6%). The patient problems coded most often are foreign body in patient, device embedded in tissue or plaque and inadequate pain relief. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Breakthe device broke | 104 | 54.7% |
| Contamination /decontamination problem | 5 | 2.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 2.6% |
| Component missing | 2 | 1.1% |
| Material fragmentation | 2 | 1.1% |
| Crackthe device cracked | 1 | 0.5% |
| Defective devicethe device was defective | 1 | 0.5% |
| Deflation problem | 1 | 0.5% |
| Detachment of device or device componentpart of the device came off | 1 | 0.5% |
| Device contaminated during manufacture or shipping | 1 | 0.5% |
| Device inoperablethe device could not be used | 1 | 0.5% |
| Difficult to advance | 1 | 0.5% |
| Failure to advance | 1 | 0.5% |
| Inadequate storage | 1 | 0.5% |
| Incorrect, inadequate or imprecise result or readings | 1 | 0.5% |
| Material deformation | 1 | 0.5% |
| Output problem | 1 | 0.5% |
| Patient device interaction problem | 1 | 0.5% |
| Temperature problem | 1 | 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) | Reports | Share |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 65 | 34.2% |
| Device embedded in tissue or plaque | 25 | 13.2% |
| Inadequate pain relief | 3 | 1.6% |
| Discomfortdiscomfort | 2 | 1.1% |
| Painpain, site not specified | 2 | 1.1% |
| Cerebrospinal fluid leakage | 1 | 0.5% |
| Headachehead pain | 1 | 0.5% |
| Needle stick/puncture | 1 | 0.5% |
| No patient involvement | 1 | 0.5% |
| Numbnessnumbness | 1 | 0.5% |
| Therapeutic response, decreased | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Pencan | All MAUDE reports |
|---|---|---|
| Reports | 190 | 26,136,888 |
| Share of that pool | — | 0% |
| Classified as death, per 1,000 reports | 0 | 9 |
| Classified as injury | 42.6% | 36.2% |
| Classified as malfunction | 55.8% | 62.3% |
| Filed by the manufacturer | 83.7% | 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."
Questions about Pencan reports
How many FDA reports name Pencan?
190 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 17 in the latest 12 months.
What kinds of events are reported?
malfunction (55.8%), injury (42.6%) and other (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (54.7%), contamination /decontamination problem (2.6%), device operates differently than expected (2.6%), component missing (1.1%) and material fragmentation (1.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (83.7%) and distributor reports (1.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Pencan 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.