MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-12-10 for B.BRAUN 332100 manufactured by B. Braun Medical Inc..
[130473766]
This report has been identified as b. Braun medical internal report number (b)(4). As reported by the user facility, it was confirmed that the batch number was unknown and the sample was not available for further evaluation. Without the actual device and/or lot number, a thorough investigation could not be performed. We will maintain this report for further references and continue to monitor other reports for similar occurrences. If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[130473767]
As reported by the user facility: event 3: complaint: customer stated the syringes in the peripheral nerve block support tray had "condensation" in them. They appeared "cloudy". No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2018-00102 |
| MDR Report Key | 8148468 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-12-10 |
| Date of Report | 2018-12-10 |
| Date Mfgr Received | 2018-11-15 |
| Date Added to Maude | 2018-12-10 |
| 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 | 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 | B.BRAUN |
| Generic Name | NERVE BLOCK TRAY (KIT) |
| Product Code | OGJ |
| Date Received | 2018-12-10 |
| Catalog Number | 332100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-12-10 |