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 2019-04-10 for PERIFIX SOFT TIP N/A 4514009 manufactured by B. Braun Melsungen Ag.
[141482763]
(b)(4). No sample has been returned for investigation. Without the actual sample (or device), a through investigation could not be performed and no specific conclusion can be drawn as the cause of the reported event. After checking the respective documentation of the production (shift record, results of worker self-inspection and in-process control, machine documentation, cleaning record etc. ) no deviations could be identified in the mentioned time period. This report is being filed as both a product problem and an adverse event due to the fact that the tip of the catheter may have remained in the patient. No intervention was done, and currently there was no serious injury to the patient reported, so the report has been classified only as a malfunction. If additional information becomes available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[141482764]
As reported by the user facility ((b)(4)): catheter breakage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2019-00109 |
| MDR Report Key | 8500107 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-04-10 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-03-02 |
| Date Facility Aware | 2019-04-10 |
| Report Date | 2019-04-10 |
| Date Reported to FDA | 2019-04-10 |
| Date Reported to Mfgr | 2019-04-10 |
| Date Mfgr Received | 2019-03-18 |
| Device Manufacturer Date | 2017-03-10 |
| Date Added to Maude | 2019-04-10 |
| 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, 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 SOFT TIP |
| Generic Name | EPIDURAL CATHETER |
| Product Code | DQR |
| Date Received | 2019-04-10 |
| Model Number | N/A |
| Catalog Number | 4514009 |
| Lot Number | 17C10A8701 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| 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, HESSEN 34212 GM 34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-10 |