BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7790557 · Received August 16, 2018

    Report

    Report Number
    1920898-2018-00644
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    August 1, 2018
    Report Date
    September 10, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908466035
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER; DEVICE SINGLE USE?: NO; DEVICE RETURNED TO MANUFACTURE: YES. INVESTIGATION SUMMARY: CUSTOMER RETURNED ( 3 ) LOOSE 1/2CC SYRINGES. CUSTOMER REPORTED SHIELD DIFFICULT TO REMOVE, NEEDLE AND HUB FOUND INSIDE CAP AND BROKEN PLUNGER ROD. THE RETURNED SYRINGES WERE EXAMINED AND 2 SYRINGES EXHIBITED A BROKEN PLUNGER. NO DAMAGE COULD BE OBSERVED ON THE REMAINING RETURNED SYRINGE (NO NEEDLE HUB SEPARATION OBSERVED ON EITHER OF THE RETURNED SYRINGES). THE 3 RETURNED SYRINGES WERE TESTED TO DETERMINE THE SHIELD REMOVAL FORCES AND THE FOLLOWING WAS OBSERVED (SPECS: SHIELD REMOVAL FORCE FOR 3/10 CC AFTER STERILIZATION IS 0.85 TO 5.95LBS): SAMPLE NUMBER: SHIELD REMOVAL FORCE (LBS): SAMPLE 1: 3.95. SAMPLE 2: 1.63. SAMPLE 3: 2.99. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7240944. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIVE (5) NOTIFICATIONS [200715117, 200715768, 200715109, 200715108, 200713390] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR SHIELD DIFFICULT TO REMOVE/DETACH, NEEDLE HUB SEPARATES AND PLUNGER ROD BROKEN ON LOT # 7240944. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE - BROKEN PLUNGER. UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE - SHIELD DIFFICULT TO REMOVE. UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE - NEEDLE HUB SEPARATES. SAMPLE WAS FORWARDED TO MANUFACTURING (HOLDREGE) ON 31 AUGUST 2018 FOR FURTHER REVIEW. ON 11SEP2018, HOLDREGE RECEIVED THREE (3) LOOSE 0.5ML, 12.7MM SYRINGES FROM REPORTED BATCH # 7240944. ALL SAMPLES ARE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. FOR THE TWO (2) SAMPLES WHICH EXHIBITED A BROKEN PLUNGER ROD, PROBABLE ROOT CAUSE IS LIKELY TO BE A JAM ON THE METRO, POST ASSEMBLY OF THE PLUNGER ROD/STOPPER INTO THE SYRINGE BARREL. AS THERE IS NO DAMAGE ASSOCIATED WITH THE PLUNGER CAP OR ANY OF THE OTHER REMAINING COMPONENTS, DAMAGE ASSOCIATED WITH DOWNSTREAM EQUIPMENT (I.E. - FORM FILL & SEAL, ETC) IS UNLIKELY. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE THERE WAS AN ISSUE WITH PLUNGER ROD BROKEN, NEEDLE HUB SEPARATING AND SHIELD DIFFICULT TO REMOVE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE THERE WAS AN ISSUE WITH PLUNGER ROD BROKEN, NEEDLE HUB SEPARATING AND SHIELD DIFFICULT TO REMOVE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628920 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 7240944 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other