BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 10932628 · Received December 2, 2020

    Report

    Report Number
    1920898-2020-01658
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 5, 2020
    Report Date
    January 25, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10/D11: CONCOMITANT MEDICAL PRODUCTS: DEVICE AVAILABLE FOR EVAL YES. D10/D11: CONCOMITANT MEDICAL PRODUCTS: RETURNED TO MANUFACTURER ON: 2020-12-28. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (3) 31GX8MM, 0.3ML INSULIN SYRINGES FROM LOT 9231336. CONSUMER REPORTED SYRINGES WON'T DRAW UP THE INSULIN. ALL 3 RETURNED SYRINGES WERE EXAMINED, THEN TESTED FOR FLOW: ALL 3 WERE ABLE TO DRAW AND EXPEL PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE NO DEFECTS WERE OBSERVED THE ALLEGED ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9231336 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO (2) NOTIFICATIONS NOTED FOR CRACKED HUBS. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE WAS UNABLE OR DIFFICULT TO ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER STATED EVERY BOX OF SYRINGES THEY GET HAS ANYWHERE FROM 3-5 SYRINGES IN EACH POLY BAG THAT ARE NOT GOOD. STATED THE CURRENT BOX THEY HAVE, THEY REMOVE THE NEEDLE CAP AND NO METAL NEEDLE IS ON THE SYRINGE. STATED THEY ALSO HAVE SYRINGES WON'T DRAW UP THE INSULIN. STATED LAST NIGHT THE FIRST SYRINGE WOULDN'T DRAW UP THE INSULIN AND THEN A 2ND AND 3RD SYRINGE DID NOT HAVE A NEEDLE ATTACHED. STATED FINALLY THE 4TH SYRINGE WORKED LAST NIGHT. 3/10 ML, 31 G, 8MM. LOT # 923133. CAT # 328512. DATE OF EVENT: (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE WAS UNABLE OR DIFFICULT TO ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER STATED EVERY BOX OF SYRINGES THEY GET HAS ANYWHERE FROM 3-5 SYRINGES IN EACH POLY BAG THAT ARE NOT GOOD. STATED THE CURRENT BOX THEY HAVE, THEY REMOVE THE NEEDLE CAP AND NO METAL NEEDLE IS ON THE SYRINGE. STATED THEY ALSO HAVE SYRINGES WON'T DRAW UP THE INSULIN. STATED LAST NIGHT THE FIRST SYRINGE WOULDN'T DRAW UP THE INSULIN AND THEN A 2ND AND 3RD SYRINGE DID NOT HAVE A NEEDLE ATTACHED. STATED FINALLY THE 4TH SYRINGE WORKED LAST NIGHT. 3/10 ML, 31 G, 8MM, LOT # 9231336, CAT # 328512, DATE OF EVENT: (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396423 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9231336

    Patients

    Seq Age Sex Outcome Treatment
    1