BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG

    MDR report key: 9437594 · Received December 9, 2019

    Report

    Report Number
    1920898-2019-01391
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    November 18, 2019
    Report Date
    January 9, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00311917048130
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF (B)(6) 2019 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9091591. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS (B)(4) NOTED FOR SCRATCH PRINT.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (2) LOOSE 1CC, 8MM SYRINGES. CUSTOMER STATES THAT THE SCALE PRINT IS SMUDGED AND PLUNGER ROD IS DIFFICULT TO MOVE. BOTH RETURNED SYRINGES WERE EXAMINED AND BOTH EXHIBITED DOUBLE PRINTED SCALE MARKINGS ON THE BARREL. HOWEVER, BOTH SAMPLES WERE TESTED AND THE PLUNGER RODS WERE ABLE TO BE EXERCISED IN THE BARREL WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9091591. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200817263, 200816349, 200816954] NOTED FOR SCRATCH PRINT. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (SMEARED INK) UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (PLUNGER DIFFICULT TO MOVE) PROCESS SUMMARY: THE PRINTER APPLIES INK FROM A SUBSTRATE TO A MOLDED BARREL THAT HAS BEEN TREATED WITH CORONA, TO GET A GOOD ADHESION OF THE INK TO THE MOLDED BARREL. THERE WAS A MAINTENANCE DISPATCH (34677) FOR DOUBLE PRINT. THE CORRECTIVE ACTION WAS GREASE GEARS, ADJUSTED PRINT PADS, RE TIMED PAD COLLAR, ADJUSTED PRINT DRUM, CHANGED PRINT PADS, AND RAISED HEATS.

    Description of Event or Problem · 0

    MATERIAL NO. 928856. BATCH NO. 9091591. IT WAS REPORTED THAT DURING USE OF THE SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG THE SCALE PRINT IS SMUDGED AND PLUNGER ROD IS DIFFICULT TO MOVE. THIS OCCURRED ON 3 SEPARATE OCCASIONS BUT THE DATE TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED SCALE PRINT SMUDGED AND PLUNGER ROD DIFFICULT TO MOVE. DOES NOT RE-USE, SAMPLES WILL BE SUBMITTED FOR EVALUATION.

    Description of Event or Problem · 0

    MATERIAL NO. 928856, BATCH NO. 9091591. IT WAS REPORTED THAT DURING USE OF THE SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG THE SCALE PRINT IS SMUDGED AND PLUNGER ROD IS DIFFICULT TO MOVE. THIS OCCURRED ON 3 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED SCALE PRINT SMUDGED AND PLUNGER ROD DIFFICULT TO MOVE. DOES NOT RE-USE, SAMPLES WILL BE SUBMITTED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 928856, BATCH NO. 9091591. IT WAS REPORTED THAT DURING USE OF THE SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG THE SCALE PRINT IS SMUDGED AND PLUNGER ROD IS DIFFICULT TO MOVE. THIS OCCURRED ON 3 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED SCALE PRINT SMUDGED AND PLUNGER ROD DIFFICULT TO MOVE. DOES NOT RE-USE, SAMPLES WILL BE SUBMITTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236959 SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 928856 9091591 00311917048130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other