MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-28 for MIDSTREAM URINE COLLECTION KIT * 842904 manufactured by Bard Medical.
[4606657]
Urine specimen container in cath kit is unable to tolerate being sent by the pneumatic tube system without frequent leakage due to cap loosening. Purchasing has been working on this, but has been unable to obtain an improved product. When cap loosens, specimen contents are spilled inside the pneumatic tube shuttle, creating a bio hazard exposure and requiring another specimen to be obtained from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3969951 |
| MDR Report Key | 3969951 |
| Date Received | 2014-07-28 |
| Date of Report | 2014-07-28 |
| Date of Event | 2014-06-30 |
| Report Date | 2014-07-28 |
| Date Reported to FDA | 2014-07-28 |
| Date Reported to Mfgr | 2014-07-31 |
| Date Added to Maude | 2014-07-31 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDSTREAM URINE COLLECTION KIT |
| Generic Name | URINE COLLECTION KIT (EXCLUDES HIV TESTING) |
| Product Code | OIE |
| Date Received | 2014-07-28 |
| Model Number | * |
| Catalog Number | 842904 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD MEDICAL |
| Manufacturer Address | 13183 HARLAND DR COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-28 |