BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.5ML 31GA 8MM

    MDR report key: 8713873 · Received June 19, 2019

    Report

    Report Number
    1920898-2019-00555
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    June 3, 2019
    Report Date
    July 17, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00311917025360
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1/2CC, 8MM, 31G WALGREENS SYRINGE IN AN OPEN POLY BAG FROM LOT # 6291787, (1) 1/2CC, 8MM, 31G WALGREENS SYRINGE IN AN OPEN POLY BAG FROM LOT # 7163854, AND (1) 1/2CC, 8MM, 31G WALGREENS SYRINGE IN AN OPEN POLY BAG FROM LOT # 8043613. CUSTOMER STATES THAT THE NEEDLE HUB STAYED IN THE SHIELD AND THE PLUNGER WAS DEFORMED. ALL RETURNED SYRINGES WERE EXAMINED AND THE SAMPLE FROM LOT # 8043613 EXHIBITED A DEFORMED STOPPER IN THE BARREL. BOTH REMAINING SYRINGES EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7163854. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6291787. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200668497, 200668512, 200668470] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8043613. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED 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. AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "ON 01JUL2019, HOLDREGE RECEIVED (3) 0.5ML, 8MM, 31GA SYRINGES, MATERIAL EACH IN A SEPARATE OPEN POLYBAG. THERE WAS (1) EACH FROM BATCHES 6291787, 7163854, AND 8043613. THE SAMPLES WERE DECONTAMINATED PER HSTR-17 AND HQA-68 PRIOR TO BEING EVALUATED. VISUAL INSPECTION OF THE SYRINGE FROM BATCH 6291787 FOUND THE NEEDLE ASSEMBLY NOT ATTACHED TO THE BARREL. THERE WAS NO DAMAGE TO THE BARREL TIP. THE HUB SHOWED SOME STRESS ON THE COLLAR, BUT IT WAS NOT CRACKED. VISUAL INSPECTION OF THE SYRINGE FROM BATCH 7163854 FOUND THE NEEDLE ASSEMBLY NOT ATTACHED TO THE BARREL. THERE WAS NO DAMAGE TO THE BARREL TIP OR TO THE NEEDLE ASSEMBLY. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.5ML, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. THERE WERE NO NOTIFICATIONS OR MAINTENANCE DISPATCHES DURING THE TIMEFRAME OF THESE BATCHES THAT PERTAINED TO THESE DEFECTS. ROOT CAUSE CANNOT BE DETERMINED. ACR19-04-007 AND SCR19-04-003 ADDRESSED THESE ISSUES BY REPLACING THE SENSOR EYES WITH CAMERAS FOR MORE ACCURATE MEASUREMENT OF RAISED NEEDLE ASSEMBLIES. VISUAL INSPECTION OF THE SYRINGE FROM BATCH 8043613 FOUND A STOPPER THAT WHEN REMOVED HAD A SLIGHTLY MISSHAPEN EDGE. IT WAS SLOPED DOWN IN TWO AREAS OF THE LEADING EDGE. INSPECTION OF THE BARREL SHOWED SOME EXCESS PLASTIC INSIDE THE END OF THE BARREL NEAR THE TIP. EFFORTS TO DISLODGE THE EXCESS PLASTIC WERE UNSUCCESSFUL. WHEN THE PLUNGER AND STOPPER WERE REINSERTED INTO THE BARREL, THE SLOPED EDGES OF THE STOPPER LINED UP WITH THE CONTOURS OF THE EXCESS PLASTIC FOUND IN THE BARREL. WHEN A CORE PIN IN THE MOLDING PRESS IS DAMAGED OR WORN, IT CAUSES EXCESS RESIN TO FLOW INTO THE MOLD WHICH WOULD CAUSE THE EXCESS PLASTIC INSIDE THE BARREL. UPON INVESTIGATION, IT WAS FOUND THAT DURING THE PRODUCTION OF THE MOLDED BARRELS THAT WERE CONSUMED INTO THE FINISHED LOT, THAT CAVITY 40 OF MOLD C-1 WAS BLOCKED, PREVENTING THE USE OF THE CAVITY FROM THAT POINT FORWARD, INDICATING THAT THE CORE PIN HAD BEEN DAMAGED ON WORN. 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 · 0

    IT WAS REPORTED THAT DURING USE THE NEEDLE HUB STAYED IN SHIELD WITH 2 BATCHES (6291787 & 7163854). IT WAS ALSO REPORTED THAT WITH BATCH 8043613 THE PLUNGER WAS DEFORMED WITH A BD SYRINGE 0.5ML 31GA 8MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 928857 BATCH NO: 8043613, 7163854, 6291787. IT WAS REPORTED THAT THERE WERE THREE EVENTS INVOLVING THREE DIFFERENT LOT NUMBERS. IN TWO OCCASIONS NEEDLE HUB STAYED IN SHIELD AND IN ONE OCCASION PLUNGER WAS DEFORMED. INITIAL REPORTER: FOUND 1 SYRINGE EACH WITH 2 LOT NUMBER NEEDLE HUB STAYED IN SHIELD. LOT # 7163854 & 6291787C 1 SYRINGE IN 3RD LOT PLUNGER DEFORMED LOT # 8043613 D.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8043613. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2018-02-12. MEDICAL DEVICE LOT #: 7163854. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2017-06-12. MEDICAL DEVICE LOT #: 6291787. MEDICAL DEVICE EXPIRATION DATE: 2021-10-31. DEVICE MANUFACTURE DATE: 2016-10-17." A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE NEEDLE HUB STAYED IN SHIELD WITH 2 BATCHES (6291787 & 7163854). IT WAS ALSO REPORTED THAT WITH BATCH 8043613 THE PLUNGER WAS DEFORMED WITH A BD SYRINGE 0.5 ML 31GA 8 MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 928857. BATCH NO: 8043613, 7163854, 6291787. IT WAS REPORTED THAT THERE WERE THREE EVENTS INVOLVING THREE DIFFERENT LOT NUMBERS. IN TWO OCCASIONS NEEDLE HUB STAYED IN SHIELD AND IN ONE OCCASION PLUNGER WAS DEFORMED. INITIAL REPORTER: FOUND 1 SYRINGE EACH WITH 2 LOT NUMBER NEEDLE HUB STAYED IN SHIELD. LOT # 7163854 & 6291787 C. 1 SYRINGE IN 3RD LOT PLUNGER DEFORMED LOT # 8043613 D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504308 BD SYRINGE 0.5ML 31GA 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10 00311917025360

    Patients

    Seq Age Sex Outcome Treatment
    1 Other