BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PLASTIPAK¿ 2ML LUER SLIP SYRINGE

    MDR report key: 6355479 · Received February 23, 2017

    Report

    Report Number
    8041187-2017-00018
    Event Type
    Injury
    Date Received
    February 23, 2017
    Date of Event
    February 10, 2017
    Report Date
    March 21, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE WITHOUT PACKAGING WAS RETURNED FOR EVALUATION. A VISUAL/MICROSCOPIC INSPECTION REVEALED A DENT ON THE SYRINGE BARREL BODY AND A CRACK NEAR THE DENT. A REVIEW OF THE DEVICE HISTORY RECORD AND QUALITY NOTIFICATIONS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6022329. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT IS UNKNOWN, HOWEVER OUR QUALITY ENGINEER NOTES THAT A PROBABLE CAUSE COULD BE THAT THE DEVICE WAS JAMMED AT THE LEAK TEST REJECT STATION AT THE 3ML ASSEMBLY MACHINE DUE TO POOR THROW OUT. POOR THROW OUT COULD CAUSE THE SYRINGE TO RUB AGAINST THE TOOLING AND BE DAMAGED. ADDITIONALLY, THE FIBER OPTIC SENSOR AT THE LEAK TEST REJECT STATION MAY NOT HAVE EFFECTIVELY DETECTED THE PART JAM BECAUSE THE COMPONENT IS TRANSPARENT. REMEDIAL ACTION REQUIRED: CAPA (B)(4) HAS BEEN INITIATED TO ADDRESS DAMAGED SYRINGES AND ACTION WILL BE TAKEN TO REPLACE THE FIBER OPTIC SENSOR TO A PHOTOELECTRIC SENSOR TO DETECT PART JAMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRACK IN A BD PLASTIPAK¿ 2ML LUER SLIP SYRINGE CAUSED A LEAKAGE AND AN INACCURATE MEDICATION DOSE DURING A CAT 2 OBSTETRIC EMERGENCY. THE ANESTHESIOLOGIST HAD TO CONVERT A SPINAL ANESTHESIA PROCEDURE TO AN EPIDURAL ONE. THERE WAS NO REPORT OF HARM OR ADDITIONAL MEDICAL INTERVENTIONS PROVIDED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135403 BD PLASTIPAK¿ 2ML LUER SLIP SYRINGE HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 6022329

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention