BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL EURO 125 S/C

    MDR report key: 9437931 · Received December 9, 2019

    Report

    Report Number
    1213809-2019-01238
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    November 22, 2019
    Report Date
    February 6, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SIGNIFICANTLY DAMAGED PACKAGE CONTAINING EIGHT DESTROYED SYRINGES AND TWO LOOSE, INTACT 5ML SYRINGES WERE RECEIVED AND EVALUATED. IT WAS OBSERVED ON THE DAMAGED AND INTACT BARRELS THAT CONTACT SMEARS WERE PRESENT THROUGHOUT THE OUTSIDE OF THE BARREL, WHICH WERE REJECTABLE PER PRODUCT SPECIFICATION. INK PERMANENCY TESTING WAS PERFORMED ON THE TWO UNDAMAGED BARRELS. NO DEFECTS WERE OBSERVED. THE PRINTING MACHINE WAS EVALUATED TO DETERMINE THE POTENTIAL SOURCE OF THE OBSERVED FOREIGN MATTER. BASED ON THE FIBROUS APPEARANCE OF THE INK SMEARS AND THE MECHANICAL CONTROLS IN PLACE AT THE MARKER IT WAS LIKELY DUE TO A BUILDUP OF INK IN THE TRAY. THIS WAS FURTHER SUPPORTED BY THE DHR REVIEW FINDINGS THAT THE CLEANING OF THE PRINTING COMPONENTS WAS NOT PERFORMED AS PER PROCEDURE. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE CLEANING PROCEDURE NOT PERFORMED CORRECTLY. THIS RESULTED IN A BUILD-UP OF INK ON THE TRAY CAUSING STRANDS OF DRIED INK TO CONTACT THE PAD ROLL THEN BECOME TRANSFERRED ONTO THE BARREL. ACCOUNTABILITY ACTIONS AND ADDITIONAL TRAINING WERE ADMINISTERED FOR THE OPERATOR INVOLVED AS OF 10/20/2019.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 5ML LL EURO 125 S/C HAS BEEN FOUND EXPERIENCING THREE OCCURRENCES OF SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: ...WE HEREBY REPORT THAT THE STERILE LUER-LOK 3-PIECE 5 ML CONCENTRIC CONE SYRINGES FOR BATCHES 9200386, 9246779 AND 9246781 HAVE A POOR IMPRESSION, WITH INK CONTAMINATION THROUGHOUT THE SYRINGE AS SHOWN IN THE PHOTOS. WHAT'S MORE, WHEN YOU SWIPE THE PRINT, IT DISAPPEARS, WHICH SUGGESTS THAT THESE UNITS CAN TRANSFER INK TO THE OTHER ITEMS THEY CONTACT. WE DO NOT YET HAVE FINAL DATA ON HOW MANY SYRINGES TO REJECT DUE TO THIS SITUATION INK STAINS ON THE SYRINGE; INK FADES WITH TOUCH

    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 #: 9200386, MEDICAL DEVICE EXPIRATION DATE: 2024-06-30, DEVICE MANUFACTURE DATE: 2019-07-19; MEDICAL DEVICE LOT #: 9246779, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-09-03; MEDICAL DEVICE LOT #: 9246781, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-09-03. A 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¿ SYRINGE 5ML LL EURO 125 S/C HAS BEEN FOUND EXPERIENCING THREE OCCURRENCES OF SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: ...WE HEREBY REPORT THAT THE STERILE LUER-LOK 3-PIECE 5 ML CONCENTRIC CONE SYRINGES FOR BATCHES 9200386, 9246779 AND 9246781 HAVE A POOR IMPRESSION, WITH INK CONTAMINATION THROUGHOUT THE SYRINGE. WHAT'S MORE, WHEN YOU SWIPE THE PRINT, IT DISAPPEARS, WHICH SUGGESTS THAT THESE UNITS CAN TRANSFER INK TO THE OTHER ITEMS THEY CONTACT. WE DO NOT YET HAVE FINAL DATA ON HOW MANY SYRINGES TO REJECT DUE TO THIS SITUATION. INK STAINS ON THE SYRINGE; INK FADES WITH TOUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237306 BD SYRINGE 5ML LL EURO 125 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309649 SEE H.10 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other