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 |