MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-29 for UNSPECIFIED BD URINE COLLECTION DEVICE UNKNOWN manufactured by Becton Dickinson.
[143583187]
There are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. (b)(4). Device expiration date: unknown. Device manufacture date: unknown. Device evaluated by mfr: 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
[143583188]
It was reported that a needle stick occurred with a unspecified bd urine cup. The following information was provided by the initial reporter, "material no. Unknown batch no. Unknown. It was reported that an employee sustain a needle stick with the vacutainer as she was peeling back the sticker. We had an employee sustain a needlestick with the vacutainer as she was peeling back the sticker. The product insert states that the? Needle? Is an? Integrated transfer device?. Can? Touch? Alone can active the suction of urine up the needle, or does the? Negative pressure? (aka vacuum) needs to be applied for the urine to flow upwards. We are trying to determine if the nurse had any potential of exposure of urine and/or if there was any chance of the nurse? S blood contaminating the patient? S urine sample. Work order notes: on 04/15/19 sent an email requesting that the customer contact me, as there was no telephone number provided. On 04/22/19 sent a 2nd email to the customer. On 04/23/19 the customer called back and stated that the incident occurred when a nurse peeled back the label on the top of the urine cup and stuck her finger in the unused needle. The customer indicated that it was a 'clean needle stick. ' she stated that it was 'dumb, user error. ' i called her back to request some follow up information. On 04/23/19 the customer called back and stated that the needle stick injury was to the nurse's thumb as she peeled the label back. The nurse went to employee occupational health service as per their protocol, and received a medical evaluation. They determined that there was no blood or body fluid exposure, and there was no follow up treatment, and the nurse returned to work. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2019-00810 |
| MDR Report Key | 8562736 |
| Date Received | 2019-04-29 |
| Date of Report | 2019-06-19 |
| Date of Event | 2019-04-05 |
| Date Mfgr Received | 2019-04-10 |
| Date Added to Maude | 2019-04-29 |
| 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 | 0 |
| Brand Name | UNSPECIFIED BD URINE COLLECTION DEVICE |
| Generic Name | URINE COLLECTION DEVICE |
| Product Code | FMH |
| Date Received | 2019-04-29 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-04-29 |