BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 8592988 · Received May 8, 2019

    Report

    Report Number
    1920898-2019-00437
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    April 23, 2019
    Report Date
    June 11, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8162648 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200766256] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RELION® INSULIN SYRINGE PLUNGER FALLS OUT. THIS OCCURRED ON 10 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328512. BATCH NO: 8162648. IT WAS REPORTED THAT WHEN THE CUSTOMER PULLS ON PLUNGER ROD, IT COMES COMPLETELY OUT. STATED THE QUALITY IS NOT GOOD. STATED 10 SYRINGES AFFECTED. SHE DOES NOT USE THEM ONCE THE PLUNGER ROD COMES OUT. VERBATIM: FROM PHONE CALL ON (B)(6) 2019 09:39:20: SPOKE WITH CONSUMER TO GET MORE CLARIFICATION ON WHAT SHE REPORTED. LOT: 8162648, ITEM: 3/10 ML, 8 MM, 31G. DECLINED REPLACEMENT. SAMPLE AVAILABLE. PET OWNER REPORTED WHEN SHE PULLS ON PLUNGER ROD, IT COMES COMPLETELY OUT. STATED THE QUALITY IS NOT GOOD. STATED 10 SYRINGES AFFECTED. SHE DOES NOT USE THEM ONCE THE PLUNGER ROD COMES OUT. STATED FIRST TIME USING PRODUCT BECAUSE SOMEONE GAVE THEM TO HER FOR HER PET. DECLINED REPLACEMENT BECAUSE SHE IS GOING TO STICK WITH ANOTHER BRAND SHE USES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RELION® INSULIN SYRINGE PLUNGER FALLS OUT. THIS OCCURRED ON 10 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328512 BATCH NO: 8162648 IT WAS REPORTED THAT WHEN THE CUSTOMER PULLS ON PLUNGER ROD, IT COMES COMPLETELY OUT. STATED THE QUALITY IS NOT GOOD. STATED 10 SYRINGES AFFECTED. SHE DOES NOT USE THEM ONCE THE PLUNGER ROD COMES OUT. VERBATIM: FROM PHONE CALL ON 2019-04-24 09:39:20: SPOKE WITH CONSUMER TO GET MORE CLARIFICATION ON WHAT SHE REPORTED. LOT: 8162648, ITEM: 3/10ML, 8MM, 31G. DECLINED REPLACEMENT. SAMPLE AVAILABLE. PET OWNER REPORTED WHEN SHE PULLS ON PLUNGER ROD, IT COMES COMPLETELY OUT. STATED THE QUALITY IS NOT GOOD. STATED 10 SYRINGES AFFECTED. SHE DOES NOT USE THEM ONCE THE PLUNGER ROD COMES OUT.. STATED FIRST TIME USING PRODUCT BECAUSE SOMEONE GAVE THEM TO HER FOR HER PET. DECLINED REPLACEMENT BECAUSE SHE IS GOING TO STICK WITH ANOTHER BRAND SHE USES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386838 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8162648 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Other