UNKNOWN BD URINE COLLECTION KIT

Additional Manufacturer Narrative

B.3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. D4. UNIQUE IDENTIFIER (UDI) #: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC MATERIAL AND LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BE REOPENED TO ASSESS THE APPROPRIATE LEVEL OF INVESTIGATION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS COLLECTED DATA TO IDENTIFY ANY EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT AFTER USING AN UNKNOWN BD URINE COLLECTION KIT, THE NEEDLE WITHIN THE TRANSFER STRAW BROKE OFF AND BECAME DISLODGED DURING USE. THE NEEDLE WAS OBSERVED TO BE LOOSE FROM THE STRAW. NO ADVERSE PATIENT OR USER IMPACT WAS REPORTED.