BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 3 ML SYRINGE LUER-LOK TIP

    MDR report key: 9607466 · Received January 20, 2020

    Report

    Report Number
    8041187-2020-00009
    Event Type
    Malfunction
    Date Received
    January 20, 2020
    Date of Event
    December 25, 2019
    Report Date
    February 18, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: ONE PHOTO AND FIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. BASED ON VERBATIM AND THE PHOTO EVALUATION, WE OBSERVED THAT CATALOGUE 302106, BATCH 9023884 MIXED IN 302113, BATCH 9052635 AND SHIPPED TO CUSTOMER; THEREFORE, THE INCIDENT CAN BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. AN INVESTIGATION WAS INITIATED BY CONDUCTING A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) FOR BOTH AFFECTED BATCH NUMBERS. THE REVIEW WAS FOCUSED ON THE ASSEMBLY OPERATION, STERILIZATION, AND FINAL SHRINK-WRAP PROCESSES. ¿ BASED ON THE ASSEMBLY PRODUCTION RUN DETAILS DOCUMENTED IN THE DHRS, BOTH LOTS WERE ASSEMBLED ON THE SAME 3ML SYRINGE ASSEMBLY LINE. HOWEVER, THE TWO BATCHES WERE NOT PRODUCED CONSECUTIVELY; A BATCH WAS PRODUCED IN BETWEEN THE TWO BATCHES IN QUESTION, WHICH INCLUDED A CHANGEOVER IN CATALOG NUMBERS. THEREFORE, IT WAS CONSIDERED UNLIKELY THAT THE TWO LOTS WOULD HAVE BECOME MIXED DURING THE ASSEMBLY PROCESS. BASED ON THIS INFORMATION, THE ASSEMBLY PROCESS WAS RULED OUT AS A POTENTIAL ROOT CAUSE OF THE SHELF CARTON MIX. NEXT, THE FOCUS OF THE INVESTIGATION SHIFTED TO THE STERILIZATION PROCESS. BASED ON A REVIEW OF THE STERILIZATION CYCLE DETAILS DOCUMENTED IN THE DHRS, IT WAS NOTED THAT SHELF CARTONS FROM THE INCORRECT LOT (CAT# 302106, LOT# 9023884) HAD BEEN STERILIZED TOGETHER WITH SHELF CARTONS FOR THE CORRECT LOT (CAT# 302113, LOT# 9051635) IN A TOTAL OF FOUR (4) STERILIZATION CYCLES. PRIOR TO UNDERGOING STERILIZATION, SHELF CARTONS ARE ARRANGED IN A PALLET CONFIGURATION. AS THE PALLETIZATION CONDUCTED PRIOR TO STERILIZATION RELIES ON A MANUAL PROCESS, THERE IS A POSSIBILITY FOR A MIX OF CATALOG/LOG NUMBERS TO BE PALLETIZED TOGETHER AS A RESULT OF HUMAN ERROR. AFTER STERILIZATION, THE SHELF CARTONS ARE THEN SHRINK-WRAPPED TO FORM A CASE. AS THE PROCESS OF PACKING THE SHELF CARTONS INTO A CASE PACK IS MANUAL, THERE IS OPPORTUNITY FOR HUMAN HANDLING ERROR, RESULTING IN AN INADVERTENT MIX OF SHELF CARTONS. BASED ON THE INVESTIGATIONS OF ALL PROCESSES, THE MOST LIKELY ROOT CAUSE IS HUMAN ERROR IN BACK TO BACK OPERATION OF LOTS DURING EITHER THE MANUAL PALLETIZATION OR SHRINK-WRAP PROCESS, CAUSING A PRODUCT SHELF CARTON MIX OF CATALOG NUMBERS. A PROJECT HAS BEEN INITIATED TO ADDRESS THIS ISSUE SO THAT IT DOES NOT OCCUR AGAIN. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD 3 ML SYRINGE LUER-LOK¿ TIP HAS BEEN FOUND EXPERIENCING (B)(4) OCCURRENCES OF CONTAINING MIXED PRODUCT BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE 3ML LUER-LOK PRODUCT(302113) OUTBOX CONTAINS 3ML SLIP PRODUCT(302106) INBOX 1BOX. ADDITIONAL INFORMATION: 1)WAS THE MIXED PRODUCT (302106, LUER-SLIP) INSIDE THE CARTON LABEL HAS 302113, LUER-LOCK BY CUSTOMER? - 8 IN-BOXES WERE DELIVERED TO THE CUSTOMER AS THE 3ML LL SYRINGE. THE CUSTOMER FOUND 1 IN-BOX OF 3ML LS SYRINGE (CAT#302106). 2)WAS IT ONLY 5 PCS (SAMPLE RETURNED) OR WHOLE BOX WITH LUER-SLIP PRODUCT? - WHOLE BOX WITH LUER-SLIP PRODUCT (100 PRODUCTS INSIDE OF 1 IN-BOX PACKAGE) 3)WHEN CUSTOMER RECEIVE THE PRODUCT WAS IT IN THE SHRINKWRAP OR INDIVIDUAL BOXES? - INDIVIDUAL BOXES.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD 3 ML SYRINGE LUER-LOK¿ TIP HAS BEEN FOUND EXPERIENCING 100 OCCURRENCES OF CONTAINING MIXED PRODUCT BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE 3ML LUER-LOK PRODUCT(302113) OUTBOX CONTAINS 3ML SLIP PRODUCT(302106) INBOX 1BOX. ADDITIONAL INFORMATION: 1)WAS THE MIXED PRODUCT (302106, LUER-SLIP) INSIDE THE CARTON LABEL HAS 302113, LUER-LOCK BY CUSTOMER? 8 IN-BOXES WERE DELIVERED TO THE CUSTOMER AS THE 3ML LL SYRINGE. THE CUSTOMER FOUND 1 IN-BOX OF 3ML LS SYRINGE (CAT#302106). 2)WAS IT ONLY 5 PCS (SAMPLE RETURNED) OR WHOLE BOX WITH LUER-SLIP PRODUCT? WHOLE BOX WITH LUER-SLIP PRODUCT (100 PRODUCTS INSIDE OF 1 IN-BOX PACKAGE) 3)WHEN CUSTOMER RECEIVE THE PRODUCT WAS IT IN THE SHRINKWRAP OR INDIVIDUAL BOXES? INDIVIDUAL BOXES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72166 BD 3 ML SYRINGE LUER-LOK TIP SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 9052635

    Patients

    Seq Age Sex Outcome Treatment
    1 Other