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 2020-02-14 for PENCAN? 4502124 manufactured by B. Braun Melsungen Ag.
[183158831]
This report has been identified as b. Braun melsungen (b)(4) internal report # (b)(4). Sample evaluation: received 1 piece of pencan 27gx4" (0. 42x103 mm) w. Guide in opened packaging together with a peel paper with batch no. 16m25g8216. Upon visual inspection, the pencan cannula was broken off. No abnormalities observed on the mandrin and the guide needle. Bmi device history record (dhr): reviewed the dhr for the batch no. 16m25g8216, no abnormalities observed during the in-process and final control inspection. Bmi root cause analysis: pencan product was assembled at bbaj and bmi performed packaging as a finished goods. According to sop, operator manually load pencan needle into the blister. Pencan needle was capped with protective cap and will be sealed and packed into duplex box and then into carton box. There was no direct contact between operator and the cannula during loading process. As pencan is manufactured by b. Braun aesculap (b)(4), this complaint was forwarded to bbaj for further investigation. Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b. Braun medical, inc.
Patient Sequence No: 1, Text Type: N, H10
[183158832]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): broken needle. The broken piece had to be removed by a surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2020-00028 |
| MDR Report Key | 9713069 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date Mfgr Received | 2020-01-20 |
| Device Manufacturer Date | 2016-11-25 |
| Date Added to Maude | 2020-02-14 |
| 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 PA 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, |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENCAN? |
| Generic Name | NEEDLE, CONDUCTION, ANESTH |
| Product Code | BSP |
| Date Received | 2020-02-14 |
| Returned To Mfg | 2020-01-28 |
| Catalog Number | 4502124 |
| Lot Number | 16M25G8216 |
| 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, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-14 |