| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNSPECIFIED BD URINE COLLECTION DEVICE | URINE COLLECTION DEVICE | BECTON DICKINSON | FMH | UNKNOWN | UNKNOWN | R | * |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-04-29 | 0 | 1. R |
Patient 1
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 1
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."