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..
[130036901]
(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
[130036902]
As reported by the user facility: event 2: 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 | 2523676-2018-00101 |
| MDR Report Key | 8148480 |
| 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 |