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 2020-03-19 for PERIFIX? 4513150 manufactured by B. Braun Melsungen Ag.
[187874212]
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. Visual inspection: the perifix catheter is broken off approx. 83 mm away from the catheter end. The shorn off part with the catheter beginning was not handed over by the customer. Summary and assessment: such damages may occur when the catheter will be withdrawn against the cannula bevel and thereby shear off. We exclude a manufacturing fault since the catheters were taken to a 100% examination and therefore no mechanical damages or manufacturing faults are allowed. Please see instructions for use: "never pull the catheter through the needle as it may otherwise shear off. " therefore we assume a fault during the application process and consider the complaint as not confirmed. 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
[187874213]
As reported by the user facility (translation of user facility information by bbm sales organization in: (b)(4). Epidural insertion catheter advancement uneventful. Noted catheter snapped upon removal of epidural dressing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2020-00061 |
| MDR Report Key | 9853482 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2018-04-16 |
| Date Added to Maude | 2020-03-19 |
| 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 | 2020-03-19 |
| Returned To Mfg | 2020-03-11 |
| Catalog Number | 4513150 |
| Lot Number | 18D16G8F01 |
| 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, 34212 GM 34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-19 |