BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 8524381 · Received April 17, 2019

    Report

    Report Number
    2243072-2019-00744
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    March 19, 2019
    Report Date
    May 9, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    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: ONE 3ML SYRINGE WITH NEEDLE ATTACHED WAS RECEIVED AND VISUALLY EVALUATED. THE SYRINGE HAD UNKNOWN MEDICATION RESIDUE VISIBLE INSIDE THE FLUID PATH AND THE NEEDLE. A SMALL WHITE PIECE OF LOOSE FOREIGN MATTER WAS OBSERVED ON THE STOPPER SURFACE IN THE FLUID PATH. THE FOREIGN MATTER APPEARED TO BE A THIN PIECE OF PLASTIC FIBER, LARGER THAN LEVEL 3 IN SIZE, WHICH IS REJECTABLE PER PRODUCT SPECIFICATION. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. THE PRODUCT IS SOLD AS SYRINGE-ONLY PRODUCT WITHOUT NEEDLE OR MEDICATION. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO DETERMINE WHETHER THE FOREIGN MATTER WAS A RESULT OF SYRINGE MANUFACTURING PROCESS, NEEDLE MANUFACTURING PROCESS OR INADVERTENTLY INTRODUCED AT SOME POINT AFTER THE PRODUCT HAS LEFT THE PLANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN MATTER INSIDE SYRINGE WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THERE WAS A PLASTIC SPECK/ RESIDUE INSIDE THE SYRINGE. 1. DESCRIPTION OF ISSUE: CONTACT REPORTED THAT WHEN CUSTOMER LOADED INSULIN INTO THE SYRINGE THERE WAS A PLASTIC SPECK/ RESIDUE INSIDE THE SYRINGE. CUSTOMER HAS NOT PLACED THE NEEDLE IN THE CARTRIDGE. CONTACT ALLEGED SHE BELIEVED THE PLASTIC RESIDUE WAS ALREADY IN THE SIRING PRIOR TO LADING INSULIN INTO IT. CUSTOMER USED A NEW SYRINGE AND SUCCESSFULLY COMPLETED LOAD SEQUENCE. 2. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? O NO. PROCEED TO STEP 3. 3. NUMBER OF OCCURRENCES:1. 4. ITEM NUMBER . O CHOOSE ONE:. ¿ 3 ML SYRINGE ¿ 309657. 5. PRODUCT LOT NUMBER: M173519 (BOX). 6. ARE SAMPLES AVAILABLE FOR INVESTIGATION? O YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)?1 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 TANDEM FOLLOW UP IS REQUIRED. 10. NOTE: PRODUCT CATEGORY NEEDLE/SYRINGE ISSUE."

    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. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN (B)(6). PMA / 510(K)#: K980987 / K151766. DEVICE EVALUATED BY MFR: A SAMPLE IS AVAILABLE FOR EVALUATION. 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 THERE WAS FOREIGN MATTER INSIDE SYRINGE WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THERE WAS A PLASTIC SPECK/ RESIDUE INSIDE THE SYRINGE. DESCRIPTION OF ISSUE: CONTACT REPORTED THAT WHEN CUSTOMER LOADED INSULIN INTO THE SYRINGE THERE WAS A PLASTIC SPECK/ RESIDUE INSIDE THE SYRINGE. CUSTOMER HAS NOT PLACED THE NEEDLE IN THE CARTRIDGE. CONTACT ALLEGED SHE BELIEVED THE PLASTIC RESIDUE WAS ALREADY IN THE SIRING PRIOR TO LADING INSULIN INTO IT. CUSTOMER USED A NEW SYRINGE AND SUCCESSFULLY COMPLETED LOAD SEQUENCE. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 3. NUMBER OF OCCURRENCES: 1. ITEM NUMBER: CHOOSE ONE: 3 ML SYRINGE ¿ 309657. PRODUCT LOT NUMBER: M173519 (BOX). ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)? 1. 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 TANDEM FOLLOW UP IS REQUIRED. NOTE: PRODUCT CATEGORY = NEEDLE/SYRINGE ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317480 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other