MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-01-13 for PERIFIX? 332098 manufactured by B. Braun Medical Inc..
[177970493]
This report has been identified as b. Braun medical internal report number (b)(4). The device involved has not been received for evaluation and the investigation is ongoing at this time. A follow up will be submitted when the investigation results become available.
Patient Sequence No: 1, Text Type: N, H10
[177970494]
As per medwatch number (b)(4): when crna was attempting to put in the catheter, she felt a slight resistance and did not continue the advancement of the catheter, and eventually decided to withdraw the catheter from the patient. It was then noticed that the blue tip/marker at the end of the catheter was not seen (approximately a centimeter) and edges seemed frayed or sheared off. Xrays were taken of lumbar spine 2-3 views, cervical spine 2-3 views and thoracic spine 2 views: no radiopaque linear density or foreign body noted (in all views). No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2019-00238 |
| MDR Report Key | 9580661 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-01-13 |
| Date of Report | 2020-02-26 |
| Date Mfgr Received | 2019-12-20 |
| Device Manufacturer Date | 2019-08-19 |
| Date Added to Maude | 2020-01-13 |
| 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 | 901 MARCON BLVD. |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4847197287 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIFIX? |
| Generic Name | EPIDURAL ANESTHESIA KIT |
| Product Code | OGE |
| Date Received | 2020-01-13 |
| Returned To Mfg | 2020-01-29 |
| Model Number | 332098 |
| Catalog Number | 332098 |
| Lot Number | 0061686301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC. |
| Manufacturer Address | 901 MARCON BLVD. ALLENTOWN PA 18109 US 18109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-13 |