MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-02 for BD BLUNT FILL NEEDLE REF 205211 NEEDLE AND SYRINGE 305211 manufactured by Becton Dickinson And Company / Bd.
[182149441]
American regent has received two complaints regarding the use of fomepizole when drawing it up in to a syringe. On two occasions the product corroded the purple plastic hub attached to the needle. The fomepizole batch number was 60-7800 and expired in 05/2018. The needle affected was a bd blunt fill needle ref 305211 made by becton dickinson and company. When the nurse was advised to use another vial and instead to use a bd eclipse needle ref 205895 same mfr as other needle they had no problem. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093485 |
| MDR Report Key | 9780007 |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-28 |
| Date of Event | 2018-08-22 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD BLUNT FILL NEEDLE REF 205211 NEEDLE AND SYRINGE |
| Generic Name | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE |
| Product Code | GAA |
| Date Received | 2020-03-02 |
| Returned To Mfg | 2018-08-22 |
| Model Number | 305211 |
| Catalog Number | 305211 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND COMPANY / BD |
| Manufacturer Address | US |
| Brand Name | BD BLUNT FILL NEEDLE REF 205211 NEEDLE AND SYRINGE |
| Generic Name | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE |
| Product Code | GAA |
| Date Received | 2020-03-02 |
| Model Number | 305211 |
| Catalog Number | 305211 |
| Device Availability | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND COMPANY / BD |
| Manufacturer Address | US |
| Brand Name | FOMEPIZOLE INJECTION 1.5GM/15ML |
| Product Code | --- |
| Date Received | 2020-03-02 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN REGENT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-02 |