BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP BULK CONVENIENCE PAK

    MDR report key: 10163092 · Received June 17, 2020

    Report

    Report Number
    1213809-2020-00393
    Event Type
    Malfunction
    Date Received
    June 17, 2020
    Date of Event
    May 23, 2020
    Report Date
    July 2, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO OPENED 10ML CONVENIENCE TRAYS CONTAINING A TOTAL OF THIRTY-THREE 10ML SYRINGES AND THREE DETACHED 20-COUNT LABELS (P/N (B)(6)) WERE RECEIVED AND EVALUATED. ONE LABEL WAS FROM BATCH 0002514 AND TWO WERE FROM BATCH 0002522. IT APPEARED THE "MOISTURE" INSIDE THE SYRINGES WAS SILICONE WITH THE NORMAL AND EXPECTED AMOUNT OBSERVED PER PRODUCT SPECIFICATION. TWO SYRINGES HAD A SINGLE BROKEN PLUNGER ROD RIB, WHICH WERE REJECTABLE PER PRODUCT SPECIFICATION. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCHES 0002522 AND 0002514 WERE INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. PLEASE NOTE THAT SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. A POTENTIAL ROOT CAUSE FOR THE BROKEN PLUNGER ROD DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCHES 0002522 AND 00022514 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED/CORRECTED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 40 BD 10ML SYRINGES LUER-LOK¿ TIP BULK CONVENIENCE PAKS EXPERIENCED FOREIGN MATTER CONTAMINATION AND DEVICE DAMAGE/DEFORMATION WHILE STIL CONSIDERED OPERABLE. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309605 BATCH NO: 0002522. VERBATIM: UPON OPENING OF PACKAGING MOISTURE WAS FOUND IN THE SYRINGES. F.10. DEVICE CODES: 2944, 1354, 1069. H.6. FDA DEVICE PROBLEM CODE(S): 2944, 1354, 1069.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 40 BD 10ML SYRINGES LUER-LOK¿ TIP BULK CONVENIENCE PAKS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: (B)(6) BATCH NO: 0002522. VERBATIM: UPON OPENING OF PACKAGING MOISTURE WAS FOUND IN THE SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 40 BD 10ML SYRINGES LUER-LOK¿ TIP BULK CONVENIENCE PAKS EXPERIENCED FOREIGN MATTER CONTAMINATION AND DEVICE DAMAGE/DEFORMATION WHILE STIL CONSIDERED OPERABLE. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309605 BATCH NO: 0002522. VERBATIM: UPON OPENING OF PACKAGING MOISTURE WAS FOUND IN THE SYRINGES.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 40 BD 10ML SYRINGES LUER-LOK¿ TIP BULK CONVENIENCE PAKS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309605 BATCH NO: 0002522. VERBATIM: UPON OPENING OF PACKAGING MOISTURE WAS FOUND IN THE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629652 BD 10ML SYRINGE LUER-LOK TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309605 0002522 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other