BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK SYRINGE

    MDR report key: 9192064 · Received October 15, 2019

    Report

    Report Number
    9614033-2019-00256
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    September 4, 2019
    Report Date
    December 5, 2019
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K151766
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 ML BD LUER-LOK¿ LUER-LOK¿ SYRINGE WAS NOT WITHDRAWING ALL OF THE INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309657 BATCH NO.: 8222972. IT WAS REPORTED THAT THE SYRINGE WAS NOT WITHDRAWING ALL OF THE INSULIN. 1. DESCRIPTION OF ISSUE: THE CUSTOMER STATED THAT WHEN SHE TRIED TO WITHDRAW INSULIN FROM THE INSULIN VIAL IT WOULD ONLY WITHDRAW AIR AND ONLY A LITTLE BIT OF INSULIN. THIS WAS THE SECOND TIME THAT THE CUSTOMER HAD USED THIS NEEDLE AND SYRINGE, CTS INFORMED THE CUSTOMER THAT THIS MAY BE CAUSING THE ISSUES THAT THE CUSTOMER HAD WITH THIS NEEDLE AND SYRINGE. THE CUSTOMER STATED THAT THE NEEDLE WAS TIGHTLY SCREWED ON TO THE SYRINGE AND THAT THE NEEDLE WAS INSERTED ONLY INTO INSULIN. THE CUSTOMER UNDERSTOOD AND ACKNOWLEDGED. 2. NUMBER OF OCCURRENCES: 1 3. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? O NO. PROCEED TO STEP 4. 6. FOR BD PRODUCT ONLY, ARE SAMPLES AVAILABLE FOR INVESTIGATION? O YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)? YES 7. DID ISSUE CAUSE ANY INJURY? IF YES, WHAT TYPE OF INJURY? NO 8. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO 9. RESOLUTION CTS EXPLAINED THAT BD MIGHT FOLLOW UP WITH CUSTOMER REGARDING RETURNING SYRINGE/NEEDLE. NO FURTHER FOLLOW UP IS REQUIRED. 10. NOTE: PRODUCT CATEGORY = NEEDLE/SYRINGE ISSUE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 ML BD LUER-LOK¿ LUER-LOK¿ SYRINGE WAS NOT WITHDRAWING ALL OF THE INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309657 BATCH NO.: 8222972. IT WAS REPORTED THAT THE SYRINGE WAS NOT WITHDRAWING ALL OF THE INSULIN. DESCRIPTION OF ISSUE: THE CUSTOMER STATED THAT WHEN SHE TRIED TO WITHDRAW INSULIN FROM THE INSULIN VIAL IT WOULD ONLY WITHDRAW AIR AND ONLY A LITTLE BIT OF INSULIN. THIS WAS THE SECOND TIME THAT THE CUSTOMER HAD USED THIS NEEDLE AND SYRINGE, CTS INFORMED THE CUSTOMER THAT THIS MAY BE CAUSING THE ISSUES THAT THE CUSTOMER HAD WITH THIS NEEDLE AND SYRINGE. THE CUSTOMER STATED THAT THE NEEDLE WAS TIGHTLY SCREWED ON TO THE SYRINGE AND THAT THE NEEDLE WAS INSERTED ONLY INTO INSULIN. THE CUSTOMER UNDERSTOOD AND ACKNOWLEDGED. NUMBER OF OCCURRENCES: 1. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 4. FOR BD PRODUCT ONLY, ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)? YES. DID ISSUE CAUSE ANY INJURY? IF YES, WHAT TYPE OF INJURY? NO. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO. RESOLUTION: CTS EXPLAINED THAT BD MIGHT FOLLOW UP WITH CUSTOMER REGARDING RETURNING SYRINGE/NEEDLE. NO FURTHER FOLLOW UP IS REQUIRED. NOTE: PRODUCT CATEGORY = NEEDLE/SYRINGE ISSUE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983941 3 ML BD LUER-LOK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 8222972 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other