BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 8945915 · Received August 29, 2019

    Report

    Report Number
    2243072-2019-01844
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    July 16, 2019
    Report Date
    September 11, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    SEE H.10
    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

    H.6. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS LOT NUMBER WAS UNKNOWN. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO ASPIRATE/DRAW UP MEDICATION WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THIS OCCURRED ON 2 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED SYRINGES WOULD NOT DRAW INSULIN. ADDITIONAL INFORMATION RECEIVED: 1. DESCRIPTION OF ISSUE: CUSTOMER REPORTED THEY HAD 2 SYRINGES THAT WOULD NOT LET THEM DRAW INSULIN INTO IT. 2. NUMBER OF OCCURRENCES: 2 3. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? O NO. PROCEED TO STEP 4. 4. ITEM NUMBER O CHOOSE ONE: ¿ 3 ML SYRINGE ¿ 309657 5. PRODUCT LOT NUMBER: CUSTOMER PROVIDED LOT # OF CARTRIDGE BOX. M220644 (BOX) 6. FOR BD PRODUCT ONLY, ARE SAMPLES AVAILABLE FOR INVESTIGATION? O NO. 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.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). PMA / 510(K)#: K980987 (IF (B)(4)) K151766 (IF (B)(4)). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO ASPIRATE/DRAW UP MEDICATION WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THIS OCCURRED ON 2 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED SYRINGES WOULD NOT DRAW INSULIN. ADDITIONAL INFORMATION RECEIVED: DESCRIPTION OF ISSUE: CUSTOMER REPORTED THEY HAD 2 SYRINGES THAT WOULD NOT LET THEM DRAW INSULIN INTO IT. NUMBER OF OCCURRENCES: 2. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 4. ITEM NUMBER CHOOSE ONE: 3 ML SYRINGE ¿ 309657. PRODUCT LOT NUMBER: CUSTOMER PROVIDED LOT # OF CARTRIDGE BOX. M220644 (BOX). FOR BD PRODUCT ONLY, ARE SAMPLES AVAILABLE FOR INVESTIGATION? NO. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740211 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other