BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.5ML 31GA 8MM

    MDR report key: 12665094 · Received October 20, 2021

    Report

    Report Number
    1920898-2021-01096
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Date of Event
    September 21, 2021
    Report Date
    September 29, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY : EXEC SUMMARY - SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. A REVIEW OF THE COMPLAINT LOT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR POLYBAG OPEN PACKAGE OR SEAL AND FOR PLUNGER CAP SEPARATES ON THIS LOT #. NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE TYPES OF EVENTS FOR THIS LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. SAMPLES RETURNED - CUSTOMER RETURNED (10) POLYBAGS FROM LOT# 1123957 (9 UNOPENED, 1 OPENED). THE CONSUMER REPORTED THAT THEY FOUND 1 PACKET OF 10 SYRINGE TO BE OPEN AND 1 PLUNGER CAP OFF OF THE SYRINGE. ALL 10 RETURNED POLYBAGS WERE EXAMINED AND IT WAS OBSERVED THAT 1 WAS RETURNED WITH AN OPEN SEAL. INSIDE OF THE OPEN POLYBAG WERE 7 SYRINGES AND A DETACHED AND DAMAGED PLUNGER CAP; NO LOOSE SYRINGE ASSEMBLY WAS RETURNED WITH THIS PLUNGER CAP. NO ISSUES WERE OBSERVED ON THE REMAINING SAMPLES. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THE OBSERVED ISSUE. PHOTOS - ON 14OCT2021 HOLDREGE RECEIVED A PHOTO COMPLAINT FROM MATERIAL 328509 AND LOT #1123957 : INITIAL EVALUATION: VISUAL EXAMINATION OF THE SAMPLE INDICATES THAT THE POLYBAG EXHIBITS AN OPEN VERTICAL SEAL HALF THE LENGTH OF THE POLYBAG. THE OPENING IS LARGE ENOUGH TO ALLOW SYRINGE(S) TO FALL OUT. PROCESS SUMMARY: THE POLYBAG IS FORMED FROM A ROLL OF WEB THAT IS MOUNTED ON A SPINDLE IN THE ACMA AUTOSPLICER. THE WEB IS THREADED THROUGH A SERIES OF ROLLERS THAT CONTROL THE TENSION AND UNWINDING OF THE ROLL. AS THE WEB APPROACHES THE SEALING AREA IT IS MANIPULATED SO THAT IT WRAPS AROUND A METAL TUBE AND THE SIDES OF THE WEB OVERLAP ALONG THE FRONT OF THE TUBE. THE OVERLAPPED WEB IS SEALED TOGETHER USING A MAGNET AND SPRING STEEL ANVIL TO FORM THE POLYBAG VERTICAL SEAL ALONG THE FRONT OF THE TUBE. THE POLYBAG IS PULLED THROUGH THE MACHINE BY THE MOVEMENT OF THE JAW ARMS. THE FUNCTIONS IN THE CROSS SEALING SYSTEM ARE UPPER AND LOWER CROSS SEALING, PERFORATION OF THE POLYBAG, AND CUTTING OF THE POLYBAG. THE CROSS SEAL ON THE POLYBAG IS FORMED BY USE OF AN AIR CYLINDER DRIVEN JAW SET. THE SEALING JAW FORMS THE POLYBAG BOTTOM AS WELL AS THE TOP OF THE PREVIOUS BAG. THE PERFORATION SERVES AS AN EASY OPEN FEATURE. BETWEEN THE SEALING JAWS RESIDES A CUTOFF KNIFE THAT SEVERS THE POLYBAG FROM THE ROLL. THIS CUTOFF ACTION COMPLETES THE FINISHED POLYBAG. WHEN THE POLYBAG IS RELEASED BY THE CROSS SEALING SYSTEM IT IS DROPPED BY GRAVITY ONTO A CHUTE THAT DIRECTS THE BAG ONTO THE EXIT CONVEYOR. DEVICE HISTORY RECORD; L2L AND LOGBOOK EVALUATION: THE SYRINGES WERE PACKAGED FROM 13JUN2021 TO 13JUN2021 AT THE FFS OPERATION. THE DEVICE HISTORY (DHR) FOR BATCH 1123957 WAS REVIEWED : DURING THE MANUFACTURING PROCESS, THE FOLLOWING INSPECTIONS ARE COMPLETED ON REGULAR INTERVALS: CORRECT QUANTITY EVERY HOUR: QUANTITY SHALL MATCH PACKAGING SPECIFICATION REQUIREMENTS. SYRINGE QUALITY EVERY HOUR: MISSING AND/OR UNASSEMBLED COMPONENTS. SYRINGE QUALITY AFTER PACKAGING EVERY HOUR: DAMAGED BAGS AND/OR SYRINGES IF A DEFECT IS FOUND DURING AN INSPECTION A QUALITY NOTIFICATION IS INITIATED. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR ISSUES RELATING TO THE ASSEMBLED SYRINGE DEFECT. MAINTENANCE DISPATCH (L2L) WAS REVIEWED, AND DISPATCH # 124463 WERE CREATED THAT WOULD CAUSE AN OPEN POLYBAG. ROOT CAUSE: THE VERTICAL SEAL WAS NOT SEALING ACROSS THE ENTIRE WIDTH OF THE BAG. THE FFS EQUIPMENT WAS STOPPING FOR ¿OPEN HEATER¿ FAULTS (LOST HEAT). CORRECTIONS: REPLACED THE VERTICAL MAGNET RELAY. ALIGNED THE VERTICAL MAGNET RELAY. CAPA/SA - BASED ON THE ABOVE INVESTIGATION NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE OR PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) ARE REQUIRED AT THIS TIME. DHR REVIEW - A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD SYRINGE 0.5ML 31GA 8MM HAD OPEN PACKAGE AND STERILITY ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE PHARMACY REPORTED 1 PACKET OF 10 SYRINGES TO BE OPEN AND 1 PLUNGER CAP OFF OF A SYRINGE. DATE OF EVENT : (B)(6) 2021. SAMPLE STATUS : AWAITING SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562658 BD SYRINGE 0.5ML 31GA 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1123957

    Patients

    Seq Age Sex Outcome Treatment
    1