UNKNOWN MANUFACTURER: 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. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THE LOT # REPORTED (191001) IS NOT A MANUFACTURED LOT FOR THIS DEVICE. THE FOLLOWING INFORMATION IS BELIEVED TO BE CORRECT, HOWEVER, WAS NOT ABLE TO BE CONFIRMED: MEDICAL DEVICE LOT #: 1910001. MEDICAL DEVICE EXPIRATION DATE: 2024-09-30. DEVICE MANUFACTURE DATE: 2019-11-07. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
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Patient 1
IT WAS REPORTED THAT THE INFUSION CLAMPS WERE NOT FUNCTIONING WITH A BD PHASEAL? INFUSION CLAMP M25. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE INFUSION CLAMPS WOULD NOT CLICK INTO PLACE OR CLOSE PROPERLY AND THAT THE TAB WOULD NOT LOCK INTO PLACE. ADDITIONALLY, THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: I WANTED TO REPORT AN ISSUE THAT TOOK PLACE TODAY WITH SEVERAL INFUSION CLAMPS WHILE AT EMORY. OUT OF 3 BOXES OF 25, SEVERAL OF THEM WOULD NOT "CLICK" INTO PLACE OR CLOSE AS THEY SHOULD, THE SMALL TAB THAT LOCKS THE 2 SIDES TOGETHER WOULDN'T LOCK. OUT OF 3 BOXES, I WOULD GUESS UP TO ~ 30% OF THE SAMPLES HAD THIS ISSUE.