BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 8544921 · Received April 24, 2019

    Report

    Report Number
    1920898-2019-00379
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    April 1, 2019
    Report Date
    May 21, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908418034
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (11) LOOSE 1ML, 31G X 8MM BD INSULIN SYRINGES (USED). CONSUMER REPORTED PLUNGER DIFFICULT TO MOVE AND STOPPER IS SHIFTED INSIDE BARREL WHEN HE'S PUSHING ON PLUNGER ROD. ALL 11 RETURNED SAMPLES WERE EXAMINED AND THE FOLLOWING WAS OBSERVED: ALL 11 SYRINGES EXHIBITED STOPPERS CONNECTED TO THEIR RESPECTIVE PLUNGER RODS. FOR 10 OUT OF THE 11 RETURNED SYRINGES - NO DIFFICULTY WHEN MOVING THE PLUNGER ROD AND NO SUBSEQUENT STOPPER SEPARATION WHILE MOVING THE PLUNGER ROD. 1 OUT OF THE 11 RETURNED SYRINGES SHOWED DIFFICULTY WHEN PULLING THE PLUNGER ROD; THIS SYRINGE WAS TESTED FOR FLOW AND FAILED. THE 1 RETURNED SYRINGE THAT FAILED THE FLOW TEST WAS THEN WIRED TESTED: IT PASSED, THE WIRE WAS ABLE TO PASS THROUGH THE LENGTH OF THE CANNULA. NO MATERIAL DEBRIS WAS OBSERVED ON THE WIRE AS IS PASSED FROM ONE END OF THE CANNULA TO THE OTHER, THEREFORE, THE CAUSE OF THE CLOG IS UNKNOWN. A SECOND FLOW TEST WAS PERFORMED ON THE SYRINGE AND IT WAS OBSERVED THAT THE FLOW WAS NOT OPTIMAL (PARTIAL CLOG). A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8092823. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200754336, 200753438, 200754193] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE ¿ THE CLOGGED CANNULA WOULD BE THE REASON WHY THE CUSTOMER WOULD THINK THE PLUNGER ROD WAS DIFFICULT TO MOVE (AS REPORTED). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (STOPPER SEPARATES). THE ROOT CAUSE FOR THE CLOGGED SYRINGE CANNOT BE DETERMINED SINCE THE MATERIAL THAT CAUSED THE CLOG IS UNKNOWN. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE (STOPPER SEPARATES) IS UNCONFIRMED.

    Description of Event or Problem · 0

    MATERIAL NO. 328418. BATCH NO. 8092823. IT WAS REPORTED THAT DURING USE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE THE PLUNGER ROD IS DIFFICULT TO REMOVE AND STOPPER SHIFTS INSIDE BARREL WHEN PUSHING ON THE PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CONSUMER REPORTED PLUNGER DIFFICULT TO MOVE AND STOPPER IS SHIFTED INSIDE BARREL WHEN HE'S PUSHING ON PLUNGER ROD. DOES NOT USE SYRINGES WHEN HE HAS ISSUES. STATED IT HAPPENED WITH 2 BOXES WITH SAME LOT NUMBER AND ITEM NUMBER. EXACT OCCURRENCE DATE UNKNOWN. LOT:8092823, ITEM: 328418, EXPIRATION DATE: 2023-04-30. SAMPLES AVAILABLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 # 8092823. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. INVESTIGATION CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURES AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUES ARE 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

    MATERIAL NO. 328418. BATCH NO. 8092823. IT WAS REPORTED THAT DURING USE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE THE PLUNGER ROD IS DIFFICULT TO REMOVE AND STOPPER SHIFTS INSIDE BARREL WHEN PUSHING ON THE PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CONSUMER REPORTED PLUNGER DIFFICULT TO MOVE AND STOPPER IS SHIFTED INSIDE BARREL WHEN HE'S PUSHING ON PLUNGER ROD. DOES NOT USE SYRINGES WHEN HE HAS ISSUES. STATED IT HAPPENED WITH 2 BOXES WITH SAME LOT NUMBER AND ITEM NUMBER. EXACT OCCURRENCE DATE UNKNOWN. LOT:8092823, ITEM: 328418, EXPIRATION DATE: 2023-04-30. SAMPLES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337737 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8092823 00382908418034

    Patients

    Seq Age Sex Outcome Treatment
    1 Other