BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM

    MDR report key: 12297635 · Received August 9, 2021

    Report

    Report Number
    1920898-2021-00876
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    July 12, 2021
    Report Date
    July 20, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE : UNKNOWN. INVESTIGATION SUMMARY : EXEC SUMMARY - SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE CLOG AND THE 3RD RELATED COMPLAINT FOR FOREIGN MATTER ON THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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 (55) 3/10CC, 8MM, 31G RELION SYRINGES (5 IN AN OPEN POLY BAG, 50 IN SEALED POLY BAGS) WITH THE SHELF CARTON FROM LOT # 0160001. CUSTOMER STATES THAT THE SYRINGES WERE CLOGGED. ALL 5 LOOSE SAMPLES AND 25 OUT OF 50 SAMPLES FROM THE SEALED POLY BAGS WERE TESTED AND ONE LOOSE SAMPLE WAS NOT ABLE TO DRAW PROPERLY. THIS SAMPLE WAS THEN WIRED AND A CLEAR GEL-LIKE MATERIAL WAS DISLODGED FROM THE CANNULA. THIS MATERIAL IS MOST LIKELY SILICONE. NO DEFECTS WERE OBSERVED ON ANY OF THE OTHER TESTED SAMPLES. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. PHOTOS - ON 27JUL2021 HOLDREGE RECEIVED A PHOTO COMPLAINT FOR MATERIAL #328512 AND LOT #0160001; SYRINGE 3ML 31GA 8MM ; INITIAL EVALUATION: TESTING PERFORMED ON THE RETURNED SAMPLE INDICATES A BLOCKED CANNULA. A MINIMAL AMOUNT OF LIQUID WOULD ENTER THE SYRINGE. MANUFACTURING EVALUATION: A REVIEW OF THE NEEDLE LINE WHERE THE CANNULA IN QUESTION WAS PRODUCED WAS COMPLETED. PROCESS SUMMARY: THIS OPERATION ASSEMBLES THE CANNULA INTO THE BARREL TIP AND APPLIES ADHESIVE TO HOLD THE CANNULA IN THE BARREL TIP. THE RACKS OF CANNULATED BARRELS THEN TRAVEL THROUGH AN OVEN WHICH USES IR LIGHT TO FACILITATE ADHESIVE RUN DOWN AND ULTRAVIOLET LIGHT TO CURE THE ADHESIVE THAT BONDS THE CANNULA TO THE BARREL TIP. THE CANNULATED BARRELS ARE THEN CONVEYED TO A MACHINE THAT INSPECTS FOR MISSING CANNULA, CANNULA HEIGHT, POINT QUALITY, AND UV ADHESIVE. IT ALSO SUPPLIES LUBE TO THE CANNULA, FEATURES TWO LUMEN BLOWS, ASSEMBLES THE SHIELD TO THE BARREL/CANNULA ASSEMBLY, AND DETECTS FOR MISSING SHIELDS. THE CASCADE (LUBE) STATION CONSISTS OF A SMALL 8-POSITION DRUM AND A LINEAR ACTUATOR TO LOAD AND UNLOAD RACKS FROM THE DRUM. AFTER THE DRUM HAS ROTATED THE RACKS INTO PLACE AT THE BOTTOM OF THE CYCLE, AN AIR CYLINDER PUSHES THE LUBE DIP BATH VERTICALLY TO A STOP POSITION. THE UP MOTION OF THE LUBE DIP BATH DIPS THE CANNULA AND RETURNS TO THE DOWN POSITION. THE DRUM WILL ROTATE TO THE 1ST LUMEN BLOW WHICH BLOWS AIR THROUGH THE CANNULA TO CLEAR IT OF ANY POSSIBLE LUBE CLOGS. THE DRUM THEN ROTATES THE RACKS BACK TO THE TOP POSITION WHERE THEY ARE UNLOADED AND ANOTHER SET OF RACKS ARE LOADED BACK IN THEIR PLACE. NEXT, THE RACKS PROCEED TO THE 2ND LUMEN BLOW STATION. THIS STATION BLOWS A HIGHER AMOUNT OF AIR THROUGH THE CANNULA AGAIN TO CLEAR IT OF ANY POSSIBLE LUBE CLOGS. THE LUMEN BLOW MANIFOLD WAS LOOSE AND NOT ALLOWING THE AIR TO BLOW THROUGH THE CANNULA PROPERLY. CORRECTIVE ACTION TAKEN : TIGHTENED THE LOOSE BOLTS IN THE MANIFOLD. CAPA/SA - BASED ON THE ABOVE INVESTIGATION NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/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 4 BD SYRINGE 0.3ML 31GA 8MM WERE CLOGGED AND HAD FOREIGN MATTER ON THE DEVICE CANNULA OR IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER :   THE CONSUMER REPORTED 3 SYRINGE NEEDLES BLOCKED TWO DIFFERENT DAYS. ONE SYRINGE WHEN CLOGGED THE CONSUMER TRIED DRAWING WATER INTO IT OVER SINK AND WHEN THE WATER WAS PRESSED OUT SOMETHING CAME OUT THE NEEDLE THAT LOOKED LIKE A MATERIAL SUBSTANCE. THE OTHER 2 SYRINGES FOUND CLOGGED WERE DISCARDED. DATE OF EVENT : (B)(6) 2021; SAMPLES STATUS : AWAITING SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194796 SYRINGE 0.3ML 31GA 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0160001

    Patients

    Seq Age Sex Outcome Treatment
    1