MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-09-12 for BD URINE COLLECTION CUP 364954 manufactured by Bd.
[2881705]
The phlebotomist accidentally stuck his finger while pushing the boric acid tube down into the urine cup lid. He went to er and received tetanus shot for the injury.
Patient Sequence No: 1, Text Type: D, B5
[10175946]
No product return is anticipated. Complaint history check yielded no other complaints for the lot reported. Device history review was conducted and no anomalies were reported. Quality will continue to monitor on monthly trend reports.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1917413-2012-00003 |
| MDR Report Key | 2747835 |
| Report Source | 06,07 |
| Date Received | 2012-09-12 |
| Date of Report | 2012-09-12 |
| Date of Event | 2012-08-14 |
| Date Mfgr Received | 2012-08-16 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2012-09-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RINA PARIKH |
| Manufacturer Street | 1 BECTON DR. |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal | 07417 |
| Manufacturer Phone | 2018474221 |
| Manufacturer G1 | BD |
| Manufacturer Street | 150 SOUTH FIRST ST. |
| Manufacturer City | BROKEN BOW NE 68822 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68822 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD URINE COLLECTION CUP |
| Generic Name | URINE COLLECTION KIT |
| Product Code | LIO |
| Date Received | 2012-09-12 |
| Catalog Number | 364954 |
| Lot Number | 1033016 |
| Device Expiration Date | 2012-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD |
| Manufacturer Address | 150 SOUTH FIRST ST. BROKEN BOW NE 68822 US 68822 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-09-12 |