MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-17 for INFLATOR SYRINGE 622510 manufactured by B. Braun Medical Inc..
[180419013]
This report has been identified as b. Braun medical internal report number (b)(4). Although it was confirmed tha the device involved is not available for 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
[180419014]
As reported by the user facility: it was reported that air leaked from the connection between the tubing and the syringe. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2020-00041 |
| MDR Report Key | 9716754 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-17 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-05-13 |
| Date Added to Maude | 2020-02-17 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 7197287 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFLATOR SYRINGE |
| Generic Name | INJECTOR AND SYRINGE, ANGI |
| Product Code | DXT |
| Date Received | 2020-02-17 |
| Model Number | 622510 |
| Catalog Number | 622510 |
| Lot Number | 0061674686 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-17 |