BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 12163551 · Received July 13, 2021

    Report

    Report Number
    1213809-2021-00492
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Date of Event
    June 14, 2021
    Report Date
    June 28, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096053
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 #: 1081409, MEDICAL DEVICE EXPIRATION DATE: 2026-02-28, DEVICE MANUFACTURE DATE: (B)(6) 2021. MEDICAL DEVICE LOT #: 1081410, MEDICAL DEVICE EXPIRATION DATE: 2026-02-28, DEVICE MANUFACTURE DATE: (B)(6) 2021. INVESTIGATION SUMMARY: SEVEN PHOTOS AND THIRTY-FIVE 10ML SYRINGES (MATERIAL 309605) WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. THE SAMPLES WERE SEPARATED BY BATCH WITH THIRTEEN FROM BATCH 1081410 AND TWENTY-TWO FROM BATCH 1081409. SIX SAMPLES FROM BATCH 1081410 AND SEVEN SAMPLES FROM BATCH 1081409 WERE OBSERVED TO HAVE DAMAGE ON THE BARREL THAT WAS NON-CONFORMING PER PRODUCT SPECIFICATION. IT WAS FOUND DURING THE INVESTIGATION THAT ONE OF THE SUB-ASSEMBLY BATCHES HAD A QUALITY NOTIFICATION GENERATED FOR POTENTIAL DAMAGED COMPONENTS RESULTING FROM A DISCONNECTED AIRLINE AT THE ASSEMBLY REJECT STATION. THE PRODUCT WAS REQUALIFIED PER PROCEDURE AT THE ASSEMBLY AND AT THE PACKAGING MACHINE DURING PRODUCTION OF BATCH 1081410. THE AFFECTED SUB-ASSEMBLY BATCH WAS USED IN THE MANUFACTURE OF THE TWO PACKAGING BATCHES RECEIVED BY THE CUSTOMER. ADDITIONALLY, THE TWO PACKAGING BATCHES WERE RUN CONSECUTIVELY. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE BATCH NUMBER 1081409 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: POTENTIAL ROOT CAUSE FOR THE INCORRECT ASSEMBLY DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE DISCONNECTED AIRLINE AT THE ASSEMBLY REJECT STATION LIKELY CONTRIBUTED TO DAMAGED PARTS GETTING THROUGH. THE DEFECT WAS DETECTED PRIOR TO BATCH 1081410 LEAVING THE FACILITY AND PRODUCT REQUALIFIED PER APPLICABLE ACCEPTABLE QUALITY LIMIT. IT IS POSSIBLE THAT NOT ALL DEFECTS WERE CONTAINED AS PART OF THE REQUALIFICATION ACTIVITIES AND A LIMITED NUMBER WITH THIS CONDITION WERE NOT DETECTED. RATIONALE: THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCHES 1081409 AND 1081410 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML LL TIP BULK CONVENIENCE PAK WAS CRACKED. THIS OCCURRED ON 80 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DURING A QUALITY CHECK THE SYRINGES WERE NOTICED TO BE CRACKED WITH DENTS ON THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060254 SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 00382903096053

    Patients

    Seq Age Sex Outcome Treatment
    1