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 2020-02-12 for DESIGN OPTIONS? 551731 manufactured by B. Braun Medical Inc..
[180421891]
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. Please note: this report is being resubmitted. The mfr report number (2523676-0190-00240) that was originally submitted on 13-jan- 2020 was incorrect. The correct mfr report number is 2523676-2019-00240.
Patient Sequence No: 1, Text Type: N, H10
[180421892]
Per medwatch number mw5091658. It was reported that the epidural catheter broke, leaving 12cm of epidural catheter in patient. No injury reported. Please note: this report is being resubmitted. The mfr report number (2523676-0190-00240) that was originally submitted on 13-jan- 2020 was incorrect. The correct mfr report number is 2523676-2019-00240.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2019-00240 |
| MDR Report Key | 9699558 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-26 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2019-12-20 |
| Date Added to Maude | 2020-02-12 |
| 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 | 2020-02-12 |
| Model Number | 551731 |
| Catalog Number | 551731 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-12 |