BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 5ML SYRINGE LUER-LOK TIP

    MDR report key: 10538406 · Received September 15, 2020

    Report

    Report Number
    1213809-2020-00627
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 26, 2020
    Report Date
    September 25, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS DISPLAYING A 5ML SYRINGE INSIDE A FULLY SEALED BLISTER PACK FROM BATCH 9200384 (P/N (B)(6)) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THE SYRINGE INSIDE THE PACKAGE HAD MULTIPLE BLACK FOREIGN MATTER PARTICLES ATTACHED TO THE OUTSIDE OF THE BARREL. THE PARTICLE APPEARED TO BE INK WITH AT LEAST ONE LARGER THAN LEVEL 4 IN SIZE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. NO SAMPLES OR PHOTOS FROM BATCH 9246781 WERE RECEIVED. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. IT WAS LIKELY DUE TO A BUILD-UP OF INK FIBERS DURING PRINTING. 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 AN UNSPECIFIED NUMBER OF BD 5ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HOSPITAL PHARMACY NOTICED BEFORE USE, THAT THERE IS A DIRT STAIN ON THE SURFACE OF PLASTIPACK 5 ML SYRINGE. APPARENTLY THIS HAS HAPPENED SEVERAL TIMES. ADDITIONAL QUESTIONS: HOW MANY EACH AFFECTED WITH THIS ISSUE AND IF THEY CAN SEND A PRODUCT SAMPLE FOR INVESTIGATION HAVE BEEN ASKED, WAITING FOR CUSTOMER REPLY.

    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 #: 9200384. MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. DEVICE MANUFACTURE DATE: 2019-07-19. MEDICAL DEVICE LOT #: 9246781. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. DEVICE MANUFACTURE DATE: 2019-09-03. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 5ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HOSPITAL PHARMACY NOTICED BEFORE USE, THAT THERE IS A DIRT STAIN ON THE SURFACE OF PLASTIPACK 5 ML SYRINGE. APPARENTLY THIS HAS HAPPENED SEVERAL TIMES. ADDITIONAL QUESTIONS: HOW MANY EACH AFFECTED WITH THIS ISSUE AND IF THEY CAN SEND A PRODUCT SAMPLE FOR INVESTIGATION HAVE BEEN ASKED, WAITING FOR CUSTOMER REPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002094 BD 5ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309649 SEE H10 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other