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 2019-05-15 for B.BRAUN 332100 manufactured by B. Braun Medical Inc..
[145134937]
(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
[145134938]
As reported by the user facility: the customer opened a tray and the syringe had a liquid substance inside that smeared when the plunger was moved. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2019-00061 |
| MDR Report Key | 8612022 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-15 |
| Date of Report | 2019-06-29 |
| Date Mfgr Received | 2019-05-02 |
| Device Manufacturer Date | 2018-09-19 |
| Date Added to Maude | 2019-05-15 |
| 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 | 861 MARCON BOULEVARD |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4842408332 |
| 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 | 2019-05-15 |
| Returned To Mfg | 2019-06-13 |
| Catalog Number | 332100 |
| Lot Number | 0061637305 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 18109 US 18109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-15 |