MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-17 for BD VACUTAINER PLASTIC URINE COLLECTION CUP 364975 manufactured by Bd.
[5220518]
It was reported that while holding a bd vacutainer plastic urine collection cup, a clinician's thumb accidentally pressed through the foil cover and was stuck by the needle used to penetrate the urine collection tube. The clinician received a tetanus shot and bacitracin was applied on the cut.
Patient Sequence No: 1, Text Type: D, B5
[12683269]
It is unknown is a sample is available for evaluation. If a sample is received, a supplemental report will be filed. Also, a review of the device history records could not be performed as a lot number for this incident was not provided. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243072-2014-00301 |
| MDR Report Key | 4356424 |
| Report Source | 05,06 |
| Date Received | 2014-12-17 |
| Date of Report | 2014-12-17 |
| Date Mfgr Received | 2014-12-03 |
| Date Added to Maude | 2014-12-24 |
| 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 | AARON LARSON |
| Manufacturer Street | ONE BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal | 07417 |
| Manufacturer Phone | 8015652406 |
| Manufacturer Street | 150 SOUTH 1ST 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 VACUTAINER PLASTIC URINE COLLECTION CUP |
| Generic Name | URINE COLLECTION CUP |
| Product Code | LIO |
| Date Received | 2014-12-17 |
| Catalog Number | 364975 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD |
| Manufacturer Address | ONE BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-12-17 |