BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 10130835 · Received June 8, 2020

    Report

    Report Number
    9610847-2020-00173
    Event Type
    Malfunction
    Date Received
    June 8, 2020
    Date of Event
    April 15, 2020
    Report Date
    May 20, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903096801
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 #: 0041918. MEDICAL DEVICE EXPIRATION DATE: 2025-01-31. DEVICE MANUFACTURE DATE: 2020-02-21. MEDICAL DEVICE LOT #: 0031290. MEDICAL DEVICE EXPIRATION DATE: 2025-01-31. DEVICE MANUFACTURE DATE: 2020-02-07. (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 0041918 AND 0031290. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL INSPECTIONS WERE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, SEVEN PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, FOREIGN MATTER WAS OBSERVED EMBEDDED WITHIN THE SYRINGE AND THE PLUNGER ROD COMPONENT WAS OBSERVED BROKEN. IT HAS BEEN DETERMINED THAT THE FOREIGN MATTER CONSISTED OF BURNT PLASTIC FROM THE MOLDING PROCESS. DEGRADED RESIN CAN BUILD UP WITHIN THE BARREL MOLD AND BREAK LOOSE INTO THE MOLDED COMPONENTS. THE DAMAGED PLUNGER ROD MOST LIKELY RESULTED FROM A JAM WITHIN THE PLUNGER AND STOPPER ASSEMBLY PROCESS. INVESTIGATION CONCLUSION: FOREIGN MATTER (LOTS: 0041918 AND 0031290) BASED ON PHOTO EVALUATION, FOREIGN MATTER HAS BEEN CONFIRMED. THE PHOTO ATTACHED SHOW THE FOREIGN MATTER DOTS EMBEDDED IN THE SYRINGE AS IS INDICATED IN THE VERBATIM IN THE RECORD OF THE COMPLAINT, HOWEVER ACCORDING OUR INTERNAL PROCEDURE (B)(4) THE EMBEDDED DOTS SIZE ARE ACCEPTABLE AND DOES NOT AFFECT THE FUNCTIONALITY OF THE PRODUCT. BD NOGALES WAS NOT ABLE TO DUPLICATE BY THE CUSTOMER INDICATED FAILURE MODES BECAUSE NOGALES ONLY HAS THE PACKAGING PROCESS OF THE SYRINGE. WE SUSPECT THAT THE FOREIGN MATTER THAT SHOWED THE SYRINGE COULD BE SYRINGE PRINTING INK. FOR A FURTHER INVESTIGATION ABOUT THE REPORTED FAILURE MODE, AN INVESTIGATION OF THE MANUFACTURING LOT OF SYRINGE ASSEMBLY AT COLUMBUS SITE IT¿S THE OPTIMAL FOR A BETTER EVALUATION OF THE DEFECT REPORTED. LOT NUMBER 0041918 (PLUNGER ROD BROKEN) BASED ON PHOTO EVALUATION, PLUNGER ROD BROKEN HAS BEEN CONFIRMED. THE PHOTO ATTACHED SHOW THE PLUNGER ROD BROKEN OF THE SYRINGE AS IS INDICATED IN THE VERBATIM IN THE RECORD OF THE COMPLAINT. A REVIEW WAS MADE IN THE PACKAGING AREA AND WAS NOT FOUND POSSIBLE ROOT CAUSE FOR THE REPORTED PLUNGER ROD BROKEN, BD NOGALES WAS NOT ABLE TO DUPLICATE THE CUSTOMER INDICATED FAILURE MODES BECAUSE NOGALES ONLY HAS THE PACKAGING PROCESS OF THE SYRINGE. PROCESS FMEA 5226 AND P-EURA RM875 WERE REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION CONCLUSION, THE REPORTED DEFECTS ARE NOT RELATED WITH OUR PACKAGING PROCESS. THEREFORE, ROOT CAUSE CANNOT BE DETERMINED. RATIONALE: NO CAPA ¿ BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME ALSO THE ROOT CAUSE WAS NOT IDENTIFIED, THEREFORE, CORRECTIVE AND PREVENTIVE ACTIONS WERE NOT IMPLEMENTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 9 BD LUER-LOK¿ SYRINGES IN THE BULK STERILE PHARMACY CONVENIENCE TRAY HAD EMBEDDED FOREIGN MATTER IN THEM, AND 1 SYRINGE HAD A BROKEN PLUNGER ROD. THESE DEFECTS WERE FOUND PRIOR TO USE IN LOT# 0041918. ADDITIONALLY, IT WAS REPORTED THAT 14 SYRINGES HAD FOREIGN MATTER IN THEIR BARRELS, WHICH WERE FOUND PRIOR TO USE IN LOT# 0031290. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT DURING INSPECTION SYRINGES WERE REJECTED FOR EMBEDDED MATERIAL, AND A BROKEN PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590717 BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 309680 SEE SECTION H.10. 30382903096801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other