MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-28 for BD VACUTAINER C&S TRANSFER STRAW KIT 364953 manufactured by Becton, Dickinson And Company.
[83852805]
Patient Sequence No: 1, Text Type: N, H10
[83852806]
Staff have reported difficulty transferring urine from specimen cups (in patients with no foley) to the bd vacutainer tube using the c&s transfer straw kit. This has resulted to exposures and near misses with urine being spilled, which is particularly concerning when dealing with patients receiving chemotherapy. The straw end of the kit has to be held in the specimen cup while the vacutainer tube is pushed down onto the needle on the other end of the straw kit. Staffs have reported difficulty in getting the needle to penetrate the yellow rubber cap on the end of the vacutainer, resulting in jarring of the specimen cup and spillage of urine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6823261 |
| MDR Report Key | 6823261 |
| Date Received | 2017-08-28 |
| Date of Report | 2017-08-10 |
| Date of Event | 2017-08-05 |
| Report Date | 2017-08-10 |
| Date Reported to FDA | 2017-08-10 |
| Date Reported to Mfgr | 2017-08-10 |
| Date Added to Maude | 2017-08-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD VACUTAINER C&S TRANSFER STRAW KIT |
| Generic Name | URINE COLLECTION DEVICE |
| Product Code | OIE |
| Date Received | 2017-08-28 |
| Catalog Number | 364953 |
| Lot Number | 7097784 |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY |
| Manufacturer Address | 1 BECTON DR. FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-28 |