BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL EUROGRAPHICS

    MDR report key: 21496659 · Received February 28, 2025

    Report

    Report Number
    1213809-2025-00147
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Date of Event
    January 30, 2025
    Report Date
    April 1, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. OTHER LOT NUMBERS INCLUDE 4046806, 4115262, 4115267 AND 4059124. OTHER EXPIRATION DATES INCLUDE 2029-01-31 AND 2029-03-31. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATES ARE 2024-02-15, 2024-04-24 AND 2024-02-28.

    Additional Manufacturer Narrative · 0

    (B)(4). SUPPLEMENTAL MDR - PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE. THIRTY-TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. FIFTEEN SAMPLES FROM BATCH 4115267 WITH TWO FULLY OPENED AND THIRTEEN SEALED OR MOSTLY SEALED, THIRTEEN SAMPLES FROM BATCH 4115262 WITH ONE FULLY OPENED AND TWELVE SEALED OR MOSTLY SEALED, TWO SAMPLES FROM BATCH 4046806 WITH ONE OPENED AND ONE SEALED, ONE SAMPLE FROM BATCH 4059124 AND ONE SAMPLE FROM BATCH 4193047 WERE RECEIVED AND EVALUATED. ALL SAMPLES WERE FOUND TO HAVE ACCEPTABLE SEAL STRENGTH WITH NO VOIDS IN THE SEAL PATTERN. THE CONDITION OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 4046806, 4115262, 4115267, 4059124 AND 4193047. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL EUROGRAPHICS PACKAGE SEAL INTEGRITY WAS POOR / QUESTIONABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM GERMAN TO ENGLISH: SYRINGES NOT SEALED CORRECTLY, PACKAGING TOO EASY TO OPEN, NO RESISTANCE WHEN OPENING, PACKAGING IS CHANGED. WHEN DID THE INCIDENT OCCUR? DURING USE. SYRINGES NOT SEALED CORRECTLY, PACKAGING TOO EASY TO OPEN, NO RESISTANCE WHEN OPENING, PACKAGING IS CHANGED. INFO RECEIVED TODAY BY REGULAR POST ALONG WITH SAMPLES. ENCLOSED YOU WILL RECEIVE THE FOLLOWING GOODS FOR REPAIR.: PLEASE STATE OUR REPAIR NO. AND ITEM NO. WHEN CHANGING THE SCREW. ERROR DESCRIPTION: SYRINGES ARE INSUFFICIENTLY SEALED (POSSIBLY NOT STERILE!?). PACKAGING IS TOO EASY TO OPEN. NO/LOW RESISTANCE WHEN OPENING (COMPARED TO 20ML SYRINGE). PACKAGING CHANGED ACCORDING TO USER (FOR 10ML SYRINGES). HKL: APPROX. 400 ST DEFECTIVE, LOT NO. REMOVED FROM RANGE. STOCK: (B)(4) UNITS. POS ARTICLE NO. / DESCRIPTION QUANTITY MEH 001 300912. SYRINGE 10 ML PLASTIPAK, 3-PIECE, LUER LOCK HUB CENTRIC, 0.2 ML SCALE LOT: 4046806. INFO: SYRINGES ARE INSUFFICIENTLY SEALED (POSSIBLY NOT STERILE!?). PACKAGING IS TOO EASY TO OPEN. " NO/LOW RESISTANCE WHEN OPENING (COMPARED TO 20MI SYRINGE). PACKAGING ACCORDING TO APPLICATION 002 300912. SYRINGE 10 ML PLASTIPAK, 3-PIECE, LUER LOCK HUB CENTRIC, 0.2 ML SCALE LOT: 4115262. INFO: SYRINGES ARE INSUFFICIENTLY SEALED (POSSIBLY NOT STERILE!?) PACKAGING IS TOO EASY TO OPEN. NO/LOW RESISTANCE WHEN OPENING (COMPARED TO 20ML SYRINGE). PACKAGING ACCORDING TO APPLICATION. 003 300912. 300912. SYRINGE 10 ML PLASTIPAK, 3-PIECE, LUER LOCK HUB CENTRIC, 0.2 ML SCALE LOT: 4115267. INFO: SYRINGES ARE INSUFFICIENTLY SEALED (POSSIBLY NOT STERILE!?). PACKAGING IS TOO EASY TO OPEN NO/LOW RESISTANCE WHEN OPENING (COMPARED TO 20MI SYRINGE). PACKAGING II. APPLICATION 004 300912. SYRINGE 10 ML PLASTIPAK, 3-PIECE, LUER LOCK HUB CENTRIC, 0.2 ML SCALE LOT: 4059124. SYRINGES ARE INSUFFICIENTLY SEALED (POSSIBLY NOT STERILE!?). PACKAGING IS TOO EASY TO OPEN NO/LOW RESISTANCE WHEN OPENING (COMPARED TO 20ML SYRINGE). PACKAGING ACCORDING TO APPLICATION 005 300912. SYRINGE 10 ML PLASTIPAK, 3-PIECE, LUER LOCK HUB CENTRIC, 0.2 ML SCALE LOT: 4193047. INFO: SYRINGES ARE INSUFFICIENTLY SEALED (POSSIBLY NOT STERILE!?). PACKAGING IS TOO EASY TO OPEN. NO/LOW RESISTANCE WHEN OPENING (COMPARED TO 20MI SYRINGE). PACKAGING ACCORDING TO APPLICATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413625 BD SYRINGE 10ML LL EUROGRAPHICS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4193047

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown