BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    MDR report key: 8632652 · Received May 22, 2019

    Report

    Report Number
    2243072-2019-00990
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    April 18, 2019
    Report Date
    June 26, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    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

    ADDITIONAL INFORMATION: MEDICAL DEVICE LOT #: 8246733. MEDICAL DEVICE EXPIRATION DATE: 8/31/2023. DEVICE MANUFACTURE DATE: 9/3/2018. ONE 3ML SYRINGE IN AN OPENED BLISTER PACK FROM BATCH #8246733 (P/N 309657) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE STOPPER ATTACHED TO THE PLUNGER ROD WAS SEATED AT AN ANGLE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. THE STOPPER ANGULARITY WAS MEASURED USING A COMPARATOR AND WAS ACCEPTABLE PER PRODUCT SPECIFICATION. ROOT CAUSE NOT DEFINED SINCE THE DEFECT WAS NOT CONFIRMED IN THE SAMPLE RECEIVED. NO CORRECTIVE ACTIONS RECOMMENDED SINCE PRODUCT DEFECT WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP PLUNGER ROD WAS NOT LEVEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309657 BATCH NO. UNKNOWN (PROVIDED :M-193356) IT WAS REPORTED THAT HER SYRINGE, ¿HAS A DEFORMITY,¿ AS THE PLUNGER IS ¿NOT LEVEL AND SHE IS CONCERNED ABOUT MEASURING OUT THE CORRECT AMOUNT OF INSULIN. 1. DESCRIPTION OF ISSUE: CUSTOMER REPORTED THAT HER SYRINGE, ¿HAS A DEFORMITY,¿ AS THE PLUNGER IS ¿NOT LEVEL AND SHE IS CONCERNED ABOUT MEASURING OUT THE CORRECT AMOUNT OF INSULIN.¿ 2. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 3. 3. NUMBER OF OCCURRENCES: 1. 4. ITEM NUMBER 3 ML SYRINGE ¿ 309657. 5. PRODUCT LOT NUMBER: M-193356, FROM BOX. 6. ARE SAMPLES AVAILABLE FOR INVESTIGATION? 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. CTS TO SEND GOODWILL ORDER FOR REPLACEMENT CARTRIDGES, TO ENSURE CUSTOMER SATISFACTION. CUSTOMER ACKNOWLEDGED AND WAS SATISFIED.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A 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). DEVICE EVALUATED BY MFR: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP PLUNGER ROD WAS NOT LEVEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309657, BATCH NO. UNKNOWN (PROVIDED :M-193356). IT WAS REPORTED THAT HER SYRINGE, ¿HAS A DEFORMITY,¿ AS THE PLUNGER IS ¿NOT LEVEL AND SHE IS CONCERNED ABOUT MEASURING OUT THE CORRECT AMOUNT OF INSULIN. DESCRIPTION OF ISSUE: CUSTOMER REPORTED THAT HER SYRINGE, ¿HAS A DEFORMITY,¿ AS THE PLUNGER IS ¿NOT LEVEL AND SHE IS CONCERNED ABOUT MEASURING OUT THE CORRECT AMOUNT OF INSULIN.¿ DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 3. NUMBER OF OCCURRENCES: 1. ITEM NUMBER: 3 ML SYRINGE ¿ 309657. PRODUCT LOT NUMBER: M-193356, FROM 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. CTS TO SEND GOODWILL ORDER FOR REPLACEMENT CARTRIDGES, TO ENSURE CUSTOMER SATISFACTION. CUSTOMER ACKNOWLEDGED AND WAS SATISFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424981 BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON 8246733 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other