MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-02-18 for BD INSULIN SYRINGE WITH THE BD ULTRA-FINE? NEEDLE 0.5 ML 328447 manufactured by Bd Medical - Diabetes Care.
[184497438]
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[184497439]
It was reported that bd insulin syringe with the bd ultra-fine? Needle 0. 5 ml was damaged. This was discovered during use. The following information was provided by the initial reporter: material no: 328447 batch no: 9231522. It was reported that the chamber where insulin is held once it is drawn into vial is broken (inside syringe is exposed). Verbatim: chamber where insulin is held once it is drawn into vial is broken (inside syringe is exposed). Rn who reported this product defect mentioned that this is how the syringe came in the package. There was no shares of plastic in the packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920898-2020-00141 |
| MDR Report Key | 9720226 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-02-18 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2019-08-19 |
| Date Added to Maude | 2020-02-18 |
| 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 | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BD MEDICAL - DIABETES CARE |
| Manufacturer Street | 1329 WEST HIGHWAY 6 |
| Manufacturer City | HOLDREGE NE 68949 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68949 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD INSULIN SYRINGE WITH THE BD ULTRA-FINE? NEEDLE 0.5 ML |
| Generic Name | SYRINGE, ANTISTICK |
| Product Code | MEG |
| Date Received | 2020-02-18 |
| Catalog Number | 328447 |
| Lot Number | 9231522 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL - DIABETES CARE |
| Manufacturer Address | 1329 WEST HIGHWAY 6 HOLDREGE NE 68949 US 68949 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-18 |