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 2020-03-18 for PERIFIX? 4513150 manufactured by B. Braun Melsungen Ag.
[187419979]
This report has been identified as b. Braun melsungen ag internal report # (b)(4). Device history record (dhr): reviewed the dhr for the batch no. 18d16g8f01, no abnormalities observed during the in-process and final control inspection. As no sample and no picture was provided, proper investigation on malfunction was not possible. Hence, the complaint is considered as not confirmed. The complaint is only taken to knowledge and filed for statistical purposes.
Patient Sequence No: 1, Text Type: N, H10
[187419980]
As reported by the user facility (translation of user facility information by bbm sales organization in: (b)(4). Epidural insertion done at l3/l4 level. Catheter advanced without difficulty. Needle pulled out without difficulty. Following which, the catheter had to be adjusted (pulled out) to level 9cm marking and it snapped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2020-00062 |
| MDR Report Key | 9849387 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2018-04-16 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 2408332 |
| 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 | PERIFIX? |
| Generic Name | CATHETER, CONDUCTION, ANESTHETIC |
| Product Code | BSO |
| Date Received | 2020-03-18 |
| Catalog Number | 4513150 |
| Lot Number | 18D16G8F0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MELSUNGEN AG |
| Manufacturer Address | CARL-BRAUN-STR. 1 MELSUNGEN, 34212 GM 34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-18 |