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 2020-02-11 for DESIGN OPTIONS? 552030 manufactured by B. Braun Medical Inc..
[180421394]
This report has been identified as b. Braun medical internal report number (b)(4). To date it is unknown if the device involved will be available evaluation, 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
[180421395]
Per medwatch number (b)(4): anesthesiologist was placing the epidural for the patient at bedside when the epidural catheter broke, leaving 5. 5-6 cm of the catheter in the patient's epidural space. Anesthesiologist covered the insertion site with a gauze. He consulted with other anesthesiologist and neurosurgery. A spinal block was performed. Patient was advised that neurosurgery would be consulting her during her hospital stay. Patient remained stable. Lower lumber x-ray was taken. Epidural catheter was not visualized. After evaluation by neurosurgery, no intervention recommended at this time. The patient will followed up later this month to discuss necessity of a ct scan for actual visualization. Neurosurgery only recommends this should she wish to proceed with having it removed. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2020-00038 |
| MDR Report Key | 9694004 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-02-11 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2019-08-20 |
| Date Added to Maude | 2020-02-11 |
| 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 | DESIGN OPTIONS? |
| Generic Name | EPIDURAL ANESTHESIA KIT |
| Product Code | OGE |
| Date Received | 2020-02-11 |
| Model Number | 552030 |
| Catalog Number | 552030 |
| Lot Number | 0061690042 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-11 |