BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 11858818 · Received May 20, 2021

    Report

    Report Number
    1213809-2021-00355
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 1, 2021
    Report Date
    June 18, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-06-02. H6: INVESTIGATION SUMMARY: FIVE PHOTOS AND FIFTEEN SYRINGES (P/N 302995) IN BLISTERPAKS WERE OBTAINED. THE SAMPLES WERE VISUALLY EVALUATED. THIRTEEN OF THE BLISTERPAKS WERE FROM BATCH NUMBER 1053192. FOUR OF THE PACKAGES WERE IN INDIVIDUAL STRIPS AND APPEARED TO HAVE BEEN TORN FORCEFULLY FROM THEIR FULL STRIP AS EVIDENCED BY THE POOR CONDITION OF THEIR EDGES. NINE PACKAGES WERE STILL PARTIALLY CONNECTED VIA THEIR PERFORATIONS IN ONE GROUP OF THREE AND THREE GROUPS OF TWO. ALL THESE PACKAGES DID NOT TEAR CLEANLY FROM ONE ANOTHER AND APPEARED TO BE VISIBLY DAMAGED FROM SEPARATION. TWO INDIVIDUAL BLISTERPAKS WERE FROM BATCH NUMBER 0342897. ONE PACKAGE HAD BEEN TORN IN THE TOP RIGHT-HAND CORNER. ONE PACKAGE WAS OBSERVED TO HAVE ITS BOTTOM WEB STRETCHED ON ONE SIDE INDICATING POOR SEPARATION. ONE PHOTO SHOWED A FIVE PACK OF BLISTERS ATTACHED TO ONE ANOTHER FROM BATCH # 1011060. IT WAS UNABLE TO BE DETERMINED FROM THE PHOTO IF THE PERFORATIONS ON THE PACKAGES WERE POOR OR NOT. POTENTIAL ROOT CAUSE FOR THE POOR PERFORATIONS DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. IT IS POSSIBLE THAT DULL SLITTERS OR LOW SLITTER PRESSURE COULD HAVE CONTRIBUTED TO THE OBSERVED DEFECT. SINCE THE REPORTED CONDITION COULD NOT BE CONFIRMED FOR BATCH NUMBER 1011060 A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED, AND CORRECTIVE ACTIONS ARE NOT NECESSARY. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATES IDENTIFIED. BATCH NUMBER 1053192 AND BATCH NUMBER 0342897 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD SYRINGE LUER-LOK¿ TIP FROM LOT 1011060, AND 1 SYRINGE FROM LOT 0342897 HAD POOR PACKAGING PERFORATION THAT TORE AND LEFT PAPER/PLASTIC SHARDS IN THE STERILE FIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FIRST SEEN WITH LOT # 0342897 RANDOMLY AND NOW SEEN AGAIN WITH LOT # 1011060. WELD FROM TRANSPARENT PLASTIC MEMBRANE NOT PROPERLY CUT AND WHEN THE SLEEVE OF 5 SYRINGES ARE PULLED APART, THE PLASTIC AND PAPER BACKING TEAR INSTEAD OF SEPARATING CLEANLY WHICH OPENS THE PACKAGING OF A STERILE PRODUCT THUS REQUIRES THE SYRINGES TO BE DISCARDED."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1011060, MEDICAL DEVICE EXPIRATION DATE: 2025-12-31, DEVICE MANUFACTURE DATE: 2021-01-11. MEDICAL DEVICE LOT #: 0342897, MEDICAL DEVICE EXPIRATION DATE: 2025-11-30, DEVICE MANUFACTURE DATE: 2020-12-07. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 BD SYRINGE LUER-LOK¿ TIP FROM LOT 1011060, AND 1 SYRINGE FROM LOT 0342897 HAD POOR PACKAGING PERFORATION THAT TORE AND LEFT PAPER/PLASTIC SHARDS IN THE STERILE FIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FIRST SEEN WITH LOT # 0342897 RANDOMLY AND NOW SEEN AGAIN WITH LOT# 1011060. WELD FROM TRANSPARENT PLASTIC MEMBRANE NOT PROPERLY CUT AND WHEN THE SLEEVE OF 5 SYRINGES ARE PULLED APART, THE PLASTIC AND PAPER BACKING TEAR INSTEAD OF SEPARATING CLEANLY WHICH OPENS THE PACKAGING OF A STERILE PRODUCT THUS REQUIRES THE SYRINGES TO BE DISCARDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756524 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 302995 SEE SECTION H.10. 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1