BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 9975542 · Received April 17, 2020

    Report

    Report Number
    3003152976-2020-00170
    Event Type
    Malfunction
    Date Received
    April 17, 2020
    Date of Event
    January 22, 2020
    Report Date
    April 3, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 #: 1902360, MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, DEVICE MANUFACTURE DATE: 2019-02-26. MEDICAL DEVICE LOT #: 1902356, MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, DEVICE MANUFACTURE DATE: 2019-02-18. INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1902360 AND 1902356, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER, RESULTS REVIEWED FOR THE REPORTED LOTS AND FOUND PRODUCT MET REQUIRED SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. INVESTIGATION CONCLUSION: NO SAMPLES OR PICTURES HAVE BEEN RECEIVED FOR INVESTIGATION. THERE ARE NOT RETAINED SAMPLES AVAILABLE FOR BULK REFERENCES SO THEY CANNOT BE EVALUATED. THEREFORE, BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. DHR OF LOT 1902360 AND 1902356 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. LUBRICANT IS EMPLOYED DURING SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED TO THIS KIND OF PRODUCTS ACCORDING TO ISO-7886-1 (MAX.VALUE 0.25MG/CM2). STOPPERS ARE ALSO LUBRICATED BY EXTERNAL SUPPLIER. DURING MANUFACTURING PROCESS BREAK OUT FORCE, SUSTAINING FORCE AND SILICONE CONTENT TESTS ARE DONE PER LOT ACCORDING TO PROCEDURES (B)(4). ON CHECKING THE RESULTS FOR THIS LOT, THEY ARE WITHIN SPECIFICATION LIMITS ACCORDING TO PROCEDURE (B)(4) (FOR 50ML SYRINGES: BREAK OUT FORCE MAX.9LBS, SUSTAINING FORCE MAX.5LBS; SILICONE WEIGHT REF: 7MG, MAX: 18MG). ACCORDING TO INSPECTION PLAN PROCEDURE (B)(4), 200 UNITS ARE INSPECTED EVERY 2 PALLETS BY QUALITY CONTROL TEAM. IN ADDITION, FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED BY OPERATOR AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES (B)(4): VISUAL INSPECTION: MOLDING: 2 INJECTIONS PER SHIFT. PRINTING: 18 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. ASSEMBLY: 18 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. FUNCTIONAL INSPECTION: PRINTING: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT PLUS ONCE PER DAY. ASSEMBLY: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT PLUS ONCE PER DAY. SINCE NO SAMPLE OR PICTURE HAS BEEN RECEIVED FOR INVESTIGATION AND NO INCIDENCE IS FOUND IN DHR REVIEW, THE ROOT CAUSE CANNOT BE DETERMINED AND COMPLAINT CANNOT BE CONFIRMED. 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 QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: CANNOT BE DETERMINED. RATIONALE: BASED ON QDA LIMITS FOR THIS PRODUCT AND DEFECT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SILICONE GEL WAS FOUND IN AN UNSPECIFIED NUMBER OF BD PLASTIPAK¿ LUER-LOK¿ SYRINGES FROM LOT#'S 1902360 AND 1902356 BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: " 22-01-2020 A LOT OF SILICONE GEL ACROSS THE SYRINGE 60ML BD LUER-LOK SYRINGES, ETO STERILIZED (EUROPEAN) - V62.300223 - 1902360/1902356 - MULTIPLE SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435651 BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other