BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 8634334 · Received May 22, 2019

    Report

    Report Number
    2243072-2019-00999
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    April 24, 2019
    Report Date
    June 26, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903096572
    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

    ONE LOOSE 3ML SYRINGE OF AN UNKNOWN BATCH WAS RECEIVED AND EVALUATED. IT WAS OBSERVED A PORTION THE STOPPER IN THE SYRINGE WAS WEDGED IN BETWEEN THE PLUNGER ROD AND THE BARREL WALL. IT APPEARED TO BE A JAMMED STOPPER CONDITION AND IS REJECTABLE PER PRODUCT SPECIFICATION. A MORE THOROUGH INVESTIGATION COULD NOT BE PERFORMED BECAUSE THE BATCH IS UNKNOWN. POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT IS MOST LIKELY DUE TO A MISALIGNMENT BETWEEN THE STOPPER AND PLUNGER ROD DIALS. BATCH # IS REQUIRED TO MAKE CORRECTIVE ACTIONS DETERMINATION. NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STOPPER WAS DEFORMED WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTACT REPORTS ONE OF THE SYRINGE NEEDLES HAS A DEFECT. CONTACT SAYS THE BLACK PLUNGER PART LOOKS WARPED, IT LOOKS A BIT MELTED. UPON FOLLOW UP THE REST OF THE FOLLOWING INTAKE: 4. ITEM NUMBER 3 ML SYRINGE 309657. 5. PRODUCT LOT NUMBER: CUSTOMER COULD NOT PROVIDE. 6. 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 INJURY. 8. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO INTERVENTION NEEDED.

    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 ((B)(6)); K151766 ((B)(6)). 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 STOPPER WAS DEFORMED WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTACT REPORTS ONE OF THE SYRINGE NEEDLES HAS A DEFECT. CONTACT SAYS THE BLACK PLUNGER PART LOOKS WARPED, IT LOOKS A BIT MELTED. UPON FOLLOW UP THE REST OF THE FOLLOWING INTAKE: ITEM NUMBER 3 ML SYRINGE ¿ 309657. PRODUCT LOT NUMBER: CUSTOMER COULD NOT PROVIDE. 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 INJURY. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425183 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN 00382903096572

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other