BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 11402666 · Received March 2, 2021

    Report

    Report Number
    1920898-2021-00249
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    December 15, 2020
    Report Date
    March 2, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST RELATED COMPLAINT FOR 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR BARREL DAMAGED/CRUSHED ON LOT # 0062057. A REVIEW OF RISK MANAGEMENT (B)(4) REVISION 14 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, BARREL DAMAGED) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: CUSTOMER RETURNED (17) LOOSE 0.3ML BD INSULIN SYRINGES. ALL RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT 1 SYRINGE EXHIBITED A DAMAGED/CRUSHED BARREL NEAREST THE FLANGE. ADDITIONALLY, THIS SAMPLE ALSO EXHIBITED A BROKEN THUMBPRESS ¿ THIS ISSUE WAS INVESTIGATED IN INVESTIGATION CHILD (B)(4). MANUFACTURING ( (B)(4) ) WILL BE NOTIFIED OF THE OBSERVED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0062057. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [ (B)(4) ] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE ON 23FEB2021, (B)(4) RECEIVED A PHOTO COMPLAINT FROM MATERIAL (B)(4) AND LOT #0062057 SYRINGE 0.3ML 31G 8MM. VISUAL INSPECTION OF THE PHOTO DISPLAYS A SYRINGE WITH A DAMAGED BARREL FLANGE AND BROKEN PLUNGER TIP AT THE END OF THE PRINTED BARREL. THE PHOTO OR COMPLAINT DOES NOT INDICATE THERE WAS DAMAGE TO THE CAP OR IF THE CAP WAS PRESENT. IT IS BELIEVED THE NONCONFORMANCE WOULD HAVE HAD TO OCCUR AT THE FORM, FILL AND SEAL (FFS) OPERATION AS THE SYRINGE WOULD HAVE BEEN EJECTED FOR MISSING CAP AND/OR WOULD NOT HAVE PROCEEDED DOWN THE FF&S TRANSFER RAIL IF DAMAGED PRIOR TO THE INDEXER. IT IS UNKNOWN WHICH 3ML FFS DID CAUSE THE DEFECT AS NO PACKAGING MATERIAL WAS IDENTIFIED IN THE COMPLAINT. PROCESS SUMMARY: A DIAL TRANSFERS THE CORRECT NUMBER OF SYRINGES TO A TUBE WHERE THEY DROP BY GRAVITY THROUGH THE TUBE COMING TO REST ON TOP OF THE POLYBAG SEALING JAWS. THE POLYBAG IS FORMED BY WEB THAT IS WRAPPED AROUND A METAL TUBE WHERE THE SIDES OF THE WEB OVERLAP AND ARE SEALED TO FORM THE VERTICAL SEAL. SEALING JAWS FORM THE POLYBAG BOTTOM, AS WELL AS THE TOP OF THE PREVIOUS POLYBAG. BETWEEN THE SEALING JAWS IS A KNIFE THAT SEVERS THE BAG FROM THE ROLL. DEVICE HISTORY RECORD; L2L AND LOGBOOK EVALUATION: THE SYRINGES WERE PACKAGED FROM 22APR2020 THRU 24APR2020 AT THE FFS OPERATION. THE DEVICE HISTORY (DHR) FOR BATCH 0062057 WAS REVIEWED AND ZERO QUALITY NOTIFICATIONS WERE WRITTEN FOR ISSUES RELATING TO THE ASSEMBLED SYRINGE DEFECT. DURING THE MANUFACTURING PROCESS, THE FOLLOWING INSPECTIONS ARE COMPLETED ON REGULAR INTERVALS: MISSING SHIELD AND CAP CHALLENGE: AT THE START OF EVERY SHIFT. CORRECT QUANTITY EVERY HOUR: QUANTITY SHALL MATCH PACKAGING SPECIFICATION REQUIREMENTS. SYRINGE QUALITY EVERY HOUR: SMEARED AND/OR SCRATCHED PRINT; MISSING PRINT, MISPLACED SCALE. 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 L2L DISPATCHES WERE ALL REVIEWED, AND THE FOLLOWING COULD BE CONTRIBUTED TO THIS COMPLAINT. ROOT CAUSE: MAINTENANCE DISPATCHES (L2L) # (B)(4) WAS CREATED ON 22APR2020 FOR BROKEN AIR JET AT THE INDEXER PRIOR TO THE TUBE. AIR JET COMB RETRACT JAMS (INDEX JAM). CORRECTIVE ACTION: THE AIR JET AIDS IN TRANSFERRING THE SYRINGES DOWN THE RAIL INTO THE INDEXER PRIOR TO GOING INTO A TUBE TO BE PACKAGED. A MISSING/BROKEN AIR JET WOULD CAUSE CONSTANT JAMS AT THE INDEXER AND COULD DAMAGE THE SYRINGE. THE BROKEN AIR JET WAS REPLACED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 17 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED HUB SEPARATION FROM THE DEVICE, PLUNGERS THAT WERE LOOSE/FELL OUT/SEPARATED, PRODUCT DAMAGE, AND SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE THE DEFECTIVE NEEDLES AND THERE ARE 17 NOW. WE HAVE BEEN DISCOVERING THEM FOR THE PAST SEVERAL MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295177 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328438 0062057 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1