BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ 1-ML SYRINGE

    MDR report key: 12782463 · Received November 9, 2021

    Report

    Report Number
    1213809-2021-00759
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 12, 2021
    Report Date
    November 17, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0329652, MEDICAL DEVICE EXPIRATION DATE: 2025-11-30, DEVICE MANUFACTURE DATE: 2021-07-29. MEDICAL DEVICE LOT #: 1146628, MEDICAL DEVICE EXPIRATION DATE: 2026-05-31, DEVICE MANUFACTURE DATE: 2021-07-29. MEDICAL DEVICE LOT #: 1172699, MEDICAL DEVICE EXPIRATION DATE: 2026-05-31, DEVICE MANUFACTURE DATE: 2021-08-06. MEDICAL DEVICE LOT #: 1172703, MEDICAL DEVICE EXPIRATION DATE: 2026-05-31, DEVICE MANUFACTURE DATE: 2021-08-02. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY FIVE PHOTOS WERE RECEIVED AND EVALUATED. ONE PHOTO SHOWED AN ALCON DEVIATION REPORT SHOWING DEFECTS BY BATCH. TWO PHOTOS SHOWED A BOX OF 1ML LUER-LOCK SYRINGES (P/N 309628) FROM AN UNKNOWN BATCH ON A WEIGH SCALE SHOWING 97 PIECES. IN ONE OF THE PHOTOS THE BOX WAS OPENED AND DISPLAYED A STRIP OF SYRINGES THAT WAS MISSING A SYRINGE. ONE PHOTO SHOWED ANOTHER BOX OF 1ML LUER-LOCK SYRINGES FROM AN UNKNOWN BATCH ON A WEIGH SCALE SHOWING 88 PIECES. ONE PHOTO SHOWED TWO OPENED 1ML LUER-LOCK SYRINGE BOXES NEXT TO EACH OTHER WITH THE BOX ON THE RIGHT APPEARING TO BE UNDERFILLED. THE OBSERVED SHORT COUNT CONDITION WAS NON-CONFORMING PER PRODUCT SPECIFICATION. DETAILED PHOTOS AND SAMPLES PHYSICALLY SHOWING THE MISSING SYRINGES FROM EACH NUMBERED BATCH WERE NOT RECEIVED. HOWEVER, COMPLAINT IS FOR SHORT COUNT AND CONFIRMED BASED ON PHOTOS SHOWING THE SHORT BOXES, DESCRIPTION. POTENTIAL ROOT CAUSE FOR THE SHORT COUNT DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THESE BATCHES ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. SINCE NO SAMPLES DISPLAYING THE BARREL/FLANGE DAMAGED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. UNUSED PHYSICAL SAMPLES OR DETAILED PHOTOS OF THE DAMAGE ARE NEEDED FOR A MORE IN-DEPTH EVALUATION. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ 1-ML SYRINGE WAS DAMAGED. THIS OCCURRED ON (B)(4) OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A NOTIFICATION THAT THE NUMBER OF THE FOLLOWING SYRINGES (ITEM: 3000443766, SYRINGE,LL,TB,3-PART,1CC (EXT)) SOMETIMES DIFFERS FROM THE NUMBER INDICATED ON THE BOX AND THAT SOME SYRINGES ARE DAMAGED. OUR BALANCE IS SET TO (B)(4) PIECES/BOX AND DURING THE MEASURING PROCESS WE NOTICED THAT THERE WERE SOME DEVIATIONS IN THE BOXES OF THE FOLLOWING BATCHES (0329652, 1146628, 1172699, 1172703) WE WEIGHED ALL THE BOXES OF THE PREVIOUS BATCHES AND OPENED 2 RANDOM BOXES TO TEST WHAT WE DISCOVERED ON THE BALANCE: IN THE FIRST BOX, ONLY (B)(4) PIECES WERE DISPLAYED, AFTER OPENING THE BOX THERE WERE SOME BUNDLES OF (B)(4) INSTEAD OF (B)(4) PIECES. IN THE SECOND BOX, (B)(4) PIECES WERE DISPLAYED, AFTER OPENING THE BOX IT WAS SEEN THAT THERE WERE TOO FEW BUNDLES OF SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ 1-ML SYRINGE WAS DAMAGED. THIS OCCURRED ON 81 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A NOTIFICATION THAT THE NUMBER OF THE FOLLOWING SYRINGES (ITEM: 3000443766, SYRINGE,LL,TB,3-PART,1CC (EXT)) SOMETIMES DIFFERS FROM THE NUMBER INDICATED ON THE BOX AND THAT SOME SYRINGES ARE DAMAGED. OUR BALANCE IS SET TO 100 PIECES/BOX AND DURING THE MEASURING PROCESS WE NOTICED THAT THERE WERE SOME DEVIATIONS IN THE BOXES OF THE FOLLOWING BATCHES (0329652, 1146628, 1172699, 1172703) WE WEIGHT ALL THE BOXES OF THE PREVIOUS BATCHES AND OPENED 2 RANDOM BOXES TO TEST WHAT WE DISCOVERED ON THE BALANCE: -IN THE FIRST BOX, ONLY 97 PIECES WERE DISPLAYED, AFTER OPENING THE BOX THERE WERE SOME BUNDLES OF 4 INSTEAD OF 5 PIECES. -IN THE SECOND BOX, 88 PIECES WERE DISPLAYED, AFTER OPENING THE BOX IT WAS SEEN THAT THERE WERE TOO FEW BUNDLES OF SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679373 BD LUER-LOK¿ 1-ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown