MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-16 for SYRINGE INTEGRA 3ML W/NDL 25X1 RB 305270 manufactured by Becton Dickinson Medical Systems.
[184161040]
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
[184161041]
It was reported that a syringe integra 3ml w/ndl 25x1 rb was missing a cap and stuck the customer. The following information was provided by the initial reporter: "it was reported the customer was stuck with a needle that did not have a cap on it when it was received. Verbatim: customer was stuck with a needle that didn't have a cap on it. It was shipped without the cap. Customer is saying that she went to the er and they advised that she be placed on hiv medication as a preventative but she is hesitant because she is pregnant. The er did blood work and will monitor her but she was wondering if bd would pay for her medical bills. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213809-2020-00189 |
| MDR Report Key | 9834024 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-23 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2016-10-25 |
| Date Added to Maude | 2020-03-16 |
| 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 | BECTON DICKINSON MEDICAL SYSTEMS |
| Manufacturer Street | ROUTE 7 AND GRACE WAY |
| Manufacturer City | CANAAN CT 06018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYRINGE INTEGRA 3ML W/NDL 25X1 RB |
| Generic Name | PISTON SYRINGE |
| Product Code | MEG |
| Date Received | 2020-03-16 |
| Model Number | 305270 |
| Catalog Number | 305270 |
| Lot Number | 6299513 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON MEDICAL SYSTEMS |
| Manufacturer Address | ROUTE 7 AND GRACE WAY CANAAN CT 06018 US 06018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-16 |