MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-01-13 for UNSPECIFIED URINE CUP UNKNOWN manufactured by Becton Dickinson.
[188322527]
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. Device manufacture date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[188322528]
It was reported that a serious injury occurred after use with a unspecified urine cup. The following information was provided by the initial reporter, "i have a couple of nurses that have been poked when discarding the blue lid for the urine containers. When they called it in to eir they were told this is an increasing problem in ih. Should we look at a different container for the lids to be discarded in to avoid this? Have you heard anything at the other sites? Staff went to emergency department but did not require blood work. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2019-02993 |
| MDR Report Key | 9581136 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-01-13 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2019-12-20 |
| Date Added to Maude | 2020-01-13 |
| 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 |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNSPECIFIED URINE CUP |
| Generic Name | URINE CUP |
| Product Code | NNI |
| Date Received | 2020-01-13 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-13 |