MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-05-08 for PENCAN N/A 4502027 manufactured by B. Braun Melsungen Ag.
[107707126]
(b)(4). We received one pencan 0,42/88 (g27 x 3 1/2") in open packaging. The returned sample was taken to a visual examination. Pre-existing damages or other faults especially at the raw cannula were not detected on the provided sample. The pencan cannula is broken off approx. 50 mm away from the cannula tip. The structure of the break on the raw cannula and also from the broken-off part shows that the cannula was bent before the break. We assume of problems during application and consider the complaint not confirmed. Device history record (dhr) : unable to review the device history record as it is an unknown batch number. Awaiting sample.
Patient Sequence No: 1, Text Type: N, H10
[107707127]
As reported by the user facility ((b)(4)): needle broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00078 |
| MDR Report Key | 7494786 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-05-08 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-04-12 |
| Date Facility Aware | 2018-05-08 |
| Report Date | 2018-05-08 |
| Date Reported to FDA | 2018-05-08 |
| Date Reported to Mfgr | 2018-05-08 |
| Date Mfgr Received | 2018-04-12 |
| Date Added to Maude | 2018-05-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JONATHAN SEVERINO |
| Manufacturer Street | 861 MARCON BLVD. |
| Manufacturer City | ALLENTOWN 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4842408332 |
| Manufacturer G1 | B. BRAUN MELSUNGEN AG |
| Manufacturer Street | CARL-BRAUN-STR. 1 |
| Manufacturer City | MELSUNGEN, 34212 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 34212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENCAN |
| Generic Name | SPINAL NEEDLE |
| Product Code | MIA |
| Date Received | 2018-05-08 |
| Returned To Mfg | 2018-04-26 |
| Model Number | N/A |
| Catalog Number | 4502027 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MELSUNGEN AG |
| Manufacturer Address | CARL-BRAUN-STR. 1 MELSUNGEN, HESSEN 34212 GM 34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-08 |