BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER LOK SYRINGE BULK NON-STERILE

    MDR report key: 10314410 · Received July 23, 2020

    Report

    Report Number
    1911916-2020-00673
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    July 3, 2020
    Report Date
    July 8, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9240677. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. DEVICE MANUFACTURE DATE: 2019-08-28. MEDICAL DEVICE LOT #: 8360746. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. DEVICE MANUFACTURE DATE: 2018-12-26. MEDICAL DEVICE LOT #: 8360754. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. DEVICE MANUFACTURE DATE: 2018-12-26. MEDICAL DEVICE LOT #: 9022892. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. DEVICE MANUFACTURE DATE: 2019-01-22. (B)(4). INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED AND EVALUATED. IT CAME IN A ZIPLOC PLASTIC BAG. IT IS A 60 ML SYRINGE. IT HAS RESIDUES OF A DRUG/SOLUTION. VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFIER LENS. IT HAS AN EMBEDDED DEGRADED RESIN IN THE BARREL WALL AT 3/8¿ FROM THE BOTTOM OF THE BARREL. IT HAS THE SIZE BETWEEN LEVEL 1 AND LEVEL 2 PER DF1-03. NO OTHER DEFECT WAS OBSERVED. THE BARREL MOLD IS N8, CAVITY 8. NO LEAKAGE TEST WAS PERFORMED TO THE SAMPLE TO PREVENT OF ANY CONTAMINATION TO THE EQUIPMENT. WITH REGARDS TO LEAKAGE PAST THE RUBBER STOPPER. A CHANGE WAS IMPLEMENTED BY CONVERTING THIS PRODUCT TO 50 ML; IT IS EXPECTED THAT THIS SYMPTOM WILL BE MITIGATED WITH THIS CHANGE. IT HAS EMBEDDED DEGRADED RESIN IN THE BARREL WALL. THIS CAN OCCUR AT THE STARTUP OF AN INJECTION MOLD/PRESS OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP IN THE BARREL AND HOT-RUNNER SYSTEM OF THE TOOLING MOLD AND PRESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. 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. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT #S 9240677, 8360746, 8360754, 9022892 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THESE BATCH #S. BASED ON THE INVESTIGATION AND SAMPLE ANALYSIS, THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. EACH OF THE LOTS LISTED IN THIS COMPLAINT WAS PRODUCED AS 60 ML AND FOR 40, 500 UNITS. THIS IS THE 1ST COMPLAINT; THEREFORE, THE CPM IS 24.6. WE WILL CONTINUE MONITORING AND TRENDING THE PERFORMANCE OF THESE LOTS FOR THIS SYMPTOM. A REVIEW OF THE APPLICABLE FMEA/PEURA (RM407) INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION. ROOT CAUSE DESCRIPTION: EMBEDDED DEGRADED RESIN. EMBEDDED IN THE BARREL WALL. THIS CAN OCCUR AT THE STARTUP OF AN INJECTION MOLD/PRESS OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP IN THE BARREL AND HOT-RUNNER SYSTEM OF THE TOOLING MOLD AND PRESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. FOR THE LEAKAGE PAST STOPPER THE CONVERSION TO 50 ML WAS IMPLEMENTED TO MITIGATE THIS SYMPTOM. RATIONALE: BASED ON THE INVESTIGATION AND SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. EACH OF THE LOTS LISTED IN THIS COMPLAINT WERE PRODUCED AS 60 ML AND FOR 40, 500 UNITS. THIS IS THE 1ST COMPLAINT; THEREFORE, THE CPM IS 24.6. WE WILL CONTINUE MONITORING AND TRENDING THE PERFORMANCE OF THESE LOTS FOR THIS SYMPTOM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 860 LUER LOK SYRINGE BULK NON-STERILE LEAKED PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE RECEIVED A COUPLE OF COMPLAINTS FROM A CUSTOMER. THE FIRST IS DUE TO THE PRESENCE OF A PARTICLE INCORPORATED INTO THE BARREL OF THE SYRINGE AND HAS BEEN LOGGED WITH OUR REFERENCE 20/0307. THE SECOND IS DUE TO THE LIQUID LEAKING PAST THE BUNG AS SOON AS THE SYRINGE WAS FILLED AND HAS BEEN LOGGED WITH OUR REFERENCE 20/0307A. BOTH SYRINGES WERE PACKED ON ONE LOT AND WERE FROM ONE OF THE FOLLOWING BATCHES: 9240677,8360746, 8360754 OR 9022892."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782319 LUER LOK SYRINGE BULK NON-STERILE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other