BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 10715013 · Received October 21, 2020

    Report

    Report Number
    1920898-2020-01449
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 30, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED: D.10 DEVICE AVAILABLE FOR EVAL?: YES. D.10 RETURNED TO MANUFACTURER ON: 2020-10-29. H.3 DEVICE RETURN TO MANUF.?: YES. H.3 DEVICE EVAL. BY MANUFACTURER?: YES. H.6 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 DOES NOT DETACH AS INTENDED ON LOT # 9231336. A REVIEW OF RISK MANAGEMENT DOCUMENT 150RMN-0001-16, REVISION 14, INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (INSULIN SYRINGE, NEEDLE HUB SEPARATES, DOES NOT DETACH AS INTENDED) WAS CAPTURED AND ADDRESSED INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 3/10CC, 8MM, 31G RELION SYRINGE IN AN OPEN POLY BAG FROM LOT # 9231336. CUSTOMER STATES THAT THE NEEDLE HUB SEPARATED WHEN REMOVING THE SHIELD AND SOME SHIELDS ARE HARD TO REMOVE. THE RETURNED SYRINGE WAS TESTED TO DETERMINE THE SHIELD REMOVAL FORCE (SPECS: SHIELD REMOVAL FORCE FOR 3/10CC AFTER STERILIZATION: 0.85-5.95 LBS.). THE SHIELD REMOVAL FORCE WAS MEASURED AS 3.61 LBS. AND THE HUB ASSEMBLY DID NOT SEPARATE FROM THE BARREL WHEN THE SHIELD WAS REMOVED. ALL OBSERVATION FALL WITHIN SPECIFICATIONS. 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 INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE 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: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE H10.

    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: COMPLAINT 1 OF 2. RELION PET OWNER REPORTED NEEDLE HUB SEPARATE WHEN REMOVING THE SHIELD STATED, SOME SHIELDS ARE HARD TO REMOVE BUT ITS HAPPENED A FEW TIMES LOT: 9231336, CATALOG: 328512, DATE OF EVENT: UNKNOWN.

    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). INVESTIGATION SUMMARY: 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 9TH. RELATED COMPLAINT FOR NEEDLE HUB SEPARATES & THE 4TH. RELATED COMPLAINT FOR DOES NOT DETACH AS INTENDED ON LOT # 9231336. A REVIEW OF RISK MANAGEMENT DOCUMENT (B)(4), INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (INSULIN SYRINGE, NEEDLE HUB SEPARATES, DOES NOT DETACH AS INTENDED) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. 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. INVESTIGATION CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: - UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED 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: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. 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 AN UNSPECIFIED NUMBER OF RELION® INSULIN SYRINGES EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 1 OF 2: RELION PET OWNER REPORTED NEEDLE HUB SEPARATE WHEN REMOVING THE SHIELD STATED, SOME SHIELDS ARE HARD TO REMOVE BUT ITS HAPPENED A FEW TIMES. LOT: 9231336, CATALOG: 328512, DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180395 RELION INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 9231336 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1