BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ - 3-PIECE SYRINGE

    MDR report key: 13620391 · Received February 28, 2022

    Report

    Report Number
    3003152976-2022-00082
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    February 8, 2022
    Report Date
    May 4, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE LOT #: ACTUAL LOT NUMBER IS UNKNOWN, HOWEVER THE CUSTOMER SUSPECTS LOTS 2111132 (MFG: 12/03/2021, EXP: 10/31/2026), 2112084 (MFG: 12/17/2021, EXP: 11/30/2026), 2103502 (MFG: 03/28/2021, EXP: 02/28/2026) AND 2106105 (MFG: 06/22/2021, EXP: 05/31/2026). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 24-MAR-2022 . H6: INVESTIGATION SUMMARY: SEVERAL SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR EVALUATION. AFTER VISUAL INSPECTION OF ALL PRODUCT, MULTIPLE DEFECTS WERE OBSERVED; FIVE SYRINGES HAD INK SPOTS ON THE BARREL, THREE SYRINGES WERE OBSERVED TO BE DAMAGED (BROKEN THUMB PRESS AND BARREL FLANGE), ONE SYRINGE WAS NOTED TO HAVE A MISASSEMBLED STOPPER, AND SEVERAL SYRINGES WERE NOTED TO HAVE A DISCOLORATION ON THE BARREL WINGS WHICH WAS IDENTIFIED TO BE BURNT MATERIAL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE SUSPECTED LOTS 2112084, 2111132, 2103502 AND 2106105, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE OBSERVED DEFECTS. AS THERE WERE MULTIPLE DEFECTS OBSERVED, THE FAILURES AND POTENTIAL CAUSES ARE FURTHER OUTLINED BELOW: SCALE MARKING ISSUE: ALTHOUGH WE COULD NOT IDENTIFY A DIRECT ISSUE, THIS CAN BE RELATED TO A MALADJUSTMENT DURING THE MARKING PROCESS CAUSING THE INK/ SPOTS TO BE SEEN ON THE OUTSIDE OF THE BARREL. DAMAGED BARREL/THUMB PRESS: THE AREAS WHERE PIECES MOVE WITHIN THE MANUFACTURING AREA ARE PROTECTED TO AVOID DAMAGE ON THE PRODUCT.. WHILE NO DIRECT ISSUES RELATED TO DAMAGED PRODUCT WERE IDENTIFIED, THIS INCIDENT IS LIKELY RELATED TO THE PRODUCT JAMMING/MOVING WITHIN THE MANUFACTURING EQUIPMENT. DISCOLORATION: MACHINES UNDERGO ROUTINE CLEANING AND MAINTENANCE AND INJECTION MACHINES ARE RAN PRIOR TO USE TO REMOVE ANY EXCESS MATERIALS, REJECTING THE FIRST FEW PIECES. MOLDING PARAMETERS WERE REVIEWED FOR ALL LOTS AND VERIFIED MACHINES WERE OPERATING WITHIN REQUIRED LIMITS. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THIS DEFECT CAN OCCUR DUE TO BURNT MATERIAL GENERATING DURING THE MOLDING PROCESS AND BECOMING INJECTED INTO THE SYRINGE AS SEEN IN THE SAMPLES RETURNED STOPPER SEPARATION FROM PLUNGER: THERE WAS NO DAMAGED OBSERVED ON THE PLUNGER ROD OR OTHER COMPONENTS THAT COULD HAVE CONTRIBUTED TO THE STOPPERS BEING IMPROPERLY ASSEMBLED. THE ASSEMBLY MACHINE HAS A VISION SYSTEM TO DETECT FOR MISSING OR IMPROPERLY ASSEMBLED STOPPERS, REJECTING ANY PRODUCT IDENTIFIED. THERE WERE NO INCIDENTS DOCUMENTED RELATED TO ANY FAILURES WITH THE DETECTION SYSTEM. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, THIS ISSUE WAS DETERMINED TO HAVE OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED 12 BD PLASTIPAK¿ - 3-PIECE SYRINGES HAD FOREIGN MATERIAL, 3 HAD DAMAGED PLUNGERS, AND 1 HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED A NUMBER OF SYRINGES WITH DEFECTS FROM OUR PACKAGING SUPPLIER...".

    Description of Event or Problem · 0

    IT WAS REPORTED 12 BD PLASTIPAK¿ - 3-PIECE SYRINGES HAD FOREIGN MATERIAL, 3 HAD DAMAGED PLUNGERS, AND 1 HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED A NUMBER OF SYRINGES WITH DEFECTS FROM OUR PACKAGING SUPPLIER..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883122 BD PLASTIPAK¿ - 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown