BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31G 6MM S/C U-100 RELION

    MDR report key: 10491967 · Received September 3, 2020

    Report

    Report Number
    1920898-2020-01162
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    August 14, 2020
    Report Date
    August 19, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138345
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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: NA. (B)(4). LEVEL B INVESTIGATION: COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR DIFFICULT/UNABLE TO OPERATE (PLUNGER MOVEMENT) ON LOT # 9231247. A REVIEW OF RISK MANAGEMENT (B)(4) REVISION 13 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, DIFFICULT/UNABLE TO OPERATE (PLUNGER MOVEMENT) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: CUSTOMER RETURNED (81) 31GX6MM, 1ML INSULIN SYRINGES FROM LOT 923124 (1 USED SYRINGE, 80 SYRINGES IN UNUSED/SEALED POLYBAGS). CONSUMER REPORTED THAT THE PLUNGER MOVES ON ITS OWN BEFORE PLACED IN VIAL. THE 1 SYRINGE RETURNED AFTER USE WAS EXAMINED, AND IT WAS OBSERVED THAT A SMALL AMOUNT OF INSULIN WAS INSIDE THE BARREL, AND THAT THE CANNULA WAS CLOGGED; THE PLUNGER ROD WAS NOT ABLE TO MOVE PROPERLY ON THIS SYRINGE. A WIRE TEST WAS PERFORMED ON THIS SYRINGE, AND THE WIRE WAS ABLE TO PASS THROUGH THE CANNULA; HOWEVER, THE MATERIAL CAUSING THE CLOG WAS NOT RETRIEVED, AND THEREFORE COULD NOT BE IDENTIFIED. 30 OUT OF THE 80 SYRINGES RETURNED UNUSED WERE EXAMINED, THEN TESTED FOR PLUNGER ROD MOVEMENT: ALL 30 SYRINGES EXHIBITED PLUNGER RODS THAT WERE ABLE TO MOVE PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THESE 30 TESTED SAMPLES. THE CLOG WOULD BE THE CAUSE FOR DIFFICULTIES OBSERVED WHEN MOVING THE PLUNGER ROD. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231247. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: 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 (CLOG). COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE FOR THIS ISSUE (CLOGGED CANNULA) COULD NOT BE DETERMINED BECAUSE THE MATERIAL CAUSING THE CLOG WAS NOT RETRIEVED OR IDENTIFIED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1.0ML 31G 6MM S/C U-100 RELION PLUNGER WAS MOVING ON IT'S OWN. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:328519, BATCH NO: 9231247. IT WAS REPORTED THAT THE PLUNGER MOVES ON ITS OWN BEFORE PLACED IN VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950922 SYRINGE 1.0ML 31G 6MM S/C U-100 RELION PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328519 9231247 00681131138345

    Patients

    Seq Age Sex Outcome Treatment
    1 Other