MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-25 for BD URINE COMPLETE CUP SET, BD VACUTAINER UNK 364957 manufactured by Bd (becton, Dickinson, And Company).
[21753290]
Recently, my wife presented at the (b)(6) hospital emergency department with classic symptoms of ureteral colic. The initial evaluating nurse appropriately asked for a clean catch urine sample and handed my wife a collection set after tearing the plastic wrap for her. Having difficulty with clothes, etc. In the bathroom, my wife found the cup difficult to open. Since the cup appeared to be the same type we have used for years, she tried pressing down on the top while twisting to open it. Unexpectedly, something in the cup pierced her finger causing bleeding. Examination of the cup set revealed only tiny graphic instructions on the wrapper that we could not decipher even with a magnifier. I was later told that this cup included a device for handling the specimen differently from those plain cups used in the past. My wife's experience indicates this device represents a risk to unsuspecting pts. This "urine complete cup set" is labeled as a "bd vacutainer" (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026274 |
| MDR Report Key | 2674181 |
| Date Received | 2012-07-25 |
| Date of Report | 2012-07-18 |
| Date of Event | 2012-06-29 |
| Date Added to Maude | 2012-07-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD URINE COMPLETE CUP SET, BD VACUTAINER |
| Generic Name | URINE COMPLETE CUP SET, BD VACUTAINER REF 364957 |
| Product Code | LIO |
| Date Received | 2012-07-25 |
| Model Number | UNK |
| Catalog Number | 364957 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD (BECTON, DICKINSON, AND COMPANY) |
| Manufacturer Address | FRANKLIN LAKES NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-25 |