BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 10715398 · Received October 21, 2020

    Report

    Report Number
    1920898-2020-01455
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 29, 2020
    Report Date
    December 1, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED/CORRECTED: D.10. DEVICE AVAILABLE FOR EVALUATION?: YES. D.10. RETURNED TO MANUFACTURER ON?: 2020-11-08. H.3. DEVICE RETURN TO MANUFACTURER?: YES. H.3. DEVICE EVAL BY MANUFACTURER?: YES. H.6.METHOD CODES: 3331, 10. H.6. RESULT CODES: 114. H.6. CONCLUSION CODES: 4315. INVESTIGATION SUMMARY: LEVEL B INVESTIGATION: COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S1; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 9TH. RELATED COMPLAINT FOR NEEDLE HUB SEPARATES & THE 4TH. RELATED COMPLAINT FOR NEEDLE SHIELD DOES NOT DETACH AS INTENDED ON LOT # 9231336. INVESTIGATION SUMMARY: CUSTOMER RETURNED THREE (3) 0.3ML INSULIN SYRINGES FROM LOT 9231336. CONSUMER REPORTED THAT NEEDLE HUB SEPARATED WHEN REMOVING SHIELD AND THE SHIELDS ARE DIFFICULT TO REMOVE. ALL 3 RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT 2 SYRINGES EXHIBITED NEEDLE HUB/SHIELD ASSEMBLIES SEPARATED FROM THE BARREL; NO DAMAGE TO THE BARREL TIPS WAS OBSERVED. THE 3RD SYRINGE WAS TESTED TO DETERMINE THE SHIELD REMOVAL FORCE (SPECS: SHIELD REMOVAL FORCE FOR 0.3 ML SYRINGE AFTER STERILIZATION IS 0.85 TO 5.95LBS) AND THE SYRINGE TESTED WITHIN SPECIFICATION AT 2.28 LBS. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THIS SYRINGE. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THE OBSERVED ISSUE. 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 [200872529] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO (2) NOTIFICATIONS [200872129, 200872284] NOTED FOR CRACKED HUBS. 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 (HUB SEPARATES) 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF RELION® INSULIN SYRINGES EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE HUB SEPARATED WHEN REMOVING SHIELD STATED, THE SHIELDS ARE DIFFICULT TO REMOVE. STATED, ITS HAPPENED SEVERAL TIMES FROM THIS BOX. LOT: 9231336, CATALOG: 328512, DATE OF EVENT: 2020-09-29, (1 SYRINGE AFFECTED).

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. (B)(4). 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 # 9231336 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO (2) NOTIFICATIONS (B)(4) NOTED FOR CRACKED HUBS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF RELION® INSULIN SYRINGES EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE HUB SEPARATED WHEN REMOVING SHIELD. STATED, THE SHIELDS ARE DIFFICULT TO REMOVE. STATED, ITS HAPPENED SEVERAL TIMES FROM THIS BOX. LOT: 9231336. CATALOG: 328512. DATE OF EVENT: (B)(6) 2020, (1 SYRINGE AFFECTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180488 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 9231336 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1