BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK TIP

    MDR report key: 10759881 · Received October 29, 2020

    Report

    Report Number
    1213809-2020-00768
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    September 30, 2020
    Report Date
    November 10, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE PHOTO DISPLAYING TWO LOOSE 1ML SYRINGES WITH NEEDLES ATTACHED WERE RECEIVED AND EVALUATED. IT WAS OBSERVED, BOTH SYRINGES IN THE PHOTO HAD THE PLUNGER ROD SEPARATED FROM THE STOPPER AND THE TIPS OF THE PLUNGER RODS WERE MISSING. THE BROKEN PLUNGER ROD DEFECT WAS REJECTABLE PER PRODUCT SPECIFICATION. A DEVICE HISTORY REVIEW WAS CONDUCTED. POTENTIAL ROOT CAUSE FOR THE BROKEN PLUNGER ROD DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD 1ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED STOPPER SEPARATION FROM THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309628 BATCH NO.: 9322110, 9108801, 0002667, 0002662, 9092993. WE HAVE RECEIVED SEVERAL COMPLAINTS ALLEGING POOR QUALITY OF THE SYRINGES BD CODE 309628. THE PATIENTS REPORT THE SYRINGES ARE 'FLIMSY', DO NOT HOLD THE MEDICATION PROPERLY AND BREAK EASILY. PATIENTS ARE UNABLE TO INJECT MEDICATION. ADDITIONAL COMMUNICATION RECEIVED: WILL YOU PLEASE PROVIDE MORE DEFINITION/DESCRIPTION REGARDING ¿FLIMSY¿? WHAT PART(S) ARE ¿FLIMSY¿? THE PLUNGER AND SEAL. WILL YOU PLEASE PROVIDE MORE DEFINITION/DESCRIPTION REGARDING ¿SYRINGES DO NOT HOLD THE MEDICATION PROPERLY¿? WHAT PART(S) IS NOT HOLDING THE MEDICATION PROPERLY OR WHAT ARE THEY EXPERIENCING WHEN THIS OCCURS? THE PATIENTS ARE INSTRUCTED TO WITHDRAW MEDICATION FROM A 3-ML VIAL AND TO CHANGE THE NEEDLE WHILE HOLDING THE SYRINGE HORIZONTALLY. WILL YOU PLEASE PROVIDE MORE DEFINITION/DESCRIPTION REGARDING ¿BREAKING EASILY¿? WHAT/WHEN ARE THEY EXPERIENCING BREAKING EASILY? THE SEAL COMES OFF THE PLUNGER.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9322110, MEDICAL DEVICE EXPIRATION DATE: 2024-11-30, DEVICE MANUFACTURE DATE: 2020-01-16. MEDICAL DEVICE LOT #: 9108801, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-05-07. MEDICAL DEVICE LOT #: 0002667, MEDICAL DEVICE EXPIRATION DATE: 2024-12-31, DEVICE MANUFACTURE DATE: 2020-01-27. MEDICAL DEVICE LOT #: 0002662, MEDICAL DEVICE EXPIRATION DATE: 2024-12-31, DEVICE MANUFACTURE DATE: 2020-01-22. MEDICAL DEVICE LOT #: 9092993, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-04-22. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 BD 1ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED STOPPER SEPARATION FROM THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309628 BATCH NO.: 9322110, 9108801, 0002667, 0002662, 9092993. WE HAVE RECEIVED SEVERAL COMPLAINTS ALLEGING POOR QUALITY OF THE SYRINGES BD CODE (B)(4). THE PATIENTS REPORT THE SYRINGES ARE 'FLIMSY', DO NOT HOLD THE MEDICATION PROPERLY AND BREAK EASILY. PATIENTS ARE UNABLE TO INJECT MEDICATION. ADDITIONAL COMMUNICATION RECEIVED: WILL YOU PLEASE PROVIDE MORE DEFINITION/DESCRIPTION REGARDING ¿FLIMSY¿? WHAT PART(S) ARE ¿FLIMSY¿? THE PLUNGER AND SEAL. WILL YOU PLEASE PROVIDE MORE DEFINITION/DESCRIPTION REGARDING ¿SYRINGES DO NOT HOLD THE MEDICATION PROPERLY¿? WHAT PART(S) IS NOT HOLDING THE MEDICATION PROPERLY OR WHAT ARE THEY EXPERIENCING WHEN THIS OCCURS? THE PATIENTS ARE INSTRUCTED TO WITHDRAW MEDICATION FROM A 3-ML VIAL AND TO CHANGE THE NEEDLE WHILE HOLDING THE SYRINGE HORIZONTALLY. WILL YOU PLEASE PROVIDE MORE DEFINITION/DESCRIPTION REGARDING ¿BREAKING EASILY¿? WHAT/WHEN ARE THEY EXPERIENCING BREAKING EASILY? -THE SEAL COMES OFF THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224602 BD 1ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 SEE H10 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1