BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGES WITH NEEDLES 1 ML, LUER SLIP, 26 G X 1/2 IN.0.45 MM X 13 MM

    MDR report key: 6746175 · Received July 27, 2017

    Report

    Report Number
    8041187-2017-00056
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    July 5, 2017
    Report Date
    September 11, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: 1 ACTUAL SAMPLE WITHOUT PACKAGING WAS RETURNED FOR INVESTIGATION. THE ACTUAL SAMPLE WAS SUBJECTED TO VISUAL INSPECTION. NEEDLE HUB WAS INSPECTED FOR FOREIGN MATTER AND NO ABNORMALITY OBSERVED. CANNULA WAS INSPECTED AND OBSERVED GEL (LUBRICATION) ON THE CANNULA. THE GEL (LUBRICATION) WAS SENT FOR FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) TEST TO MATCH WITH THE SILICON LUBRICATION USED IN THE MANUFACTURING. THE FTIR RESULTS SHOWS THAT THE GEL ON CANNULA HAVE SIMILAR SPECTRUM WITH THAT OF THE SILICON LUBRICATION USED IN THE MANUFACTURING. INVESTIGATION CONCLUSION: OBSERVED GEL (LUBRICATION) ON THE CANNULA FROM THE RETURNED SAMPLE. ROOT CAUSE DESCRIPTION: THE PROBABLE CAUSE COULD HAVE HAPPENED AT THE LUBE STATION WHERE THE GEL (LUBRICATION) MIGHT BUILD UP AT THE CASCADING BLOCK WHICH RESULTED THE GEL TO BE STICK ON THE CANNULA SURFACE DURING PROCESSING. RATIONALE: ACTION WILL BE TAKEN. DHR: COMPLAINT NUMBER: (B)(4), CAPA CHILD PR#: (B)(4), BUSINESS: MPS, CATALOG NUMBER: 301321, PRODUCT DESCRIPTION: SYRINGE 1ML LS 28GA 1/2IN, LOT/BATCH NUMBER: 7018480, EXPIRATION DATE: 31 JAN 2022. SYRINGE DHR BATCH # 7018480: REVIEWED SYRINGE DHR AND NO QUALITY NOTIFICATION WAS RAISED FOR THE REPORTED BATCH. NO ABNORMALITY DETECTED DURING PRODUCTION OF THE REPORTED BATCH. ASSEMBLED NEEDLE DHR, CATALOGUE # 8004203, BATCH# 7024200: REVIEWED ASSEMBLED NEEDLE DHR AND NO QUALITY NOTIFICATION WAS RAISED FOR THE REPORTED BATCH. NO ABNORMALITY DETECTED DURING PRODUCTION OF THE REPORTED BATCH. MANUFACTURING REVIEW: THE PREVENTATIVE MAINTENANCE, CALIBRATION AND EQUIPMENT HISTORY RECORDS WERE REVIEWED AND NO ABNORMALITY WAS OBSERVED. CONCLUSION: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. OBSERVED GEL (LUBRICATION) ON THE CANNULA FROM THE RETURNED SAMPLE. PRODUCT WAS NOT WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. FOR DEVICES WITHOUT 510(K) NUMBERS: PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND ON A BD¿ SYRINGES WITH NEEDLES 1 ML, LUER SLIP, 26 G X 1/2 IN.0.45 MM X 13 MM PRIOR TO USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529287 BD¿ SYRINGES WITH NEEDLES 1 ML, LUER SLIP, 26 G X 1/2 IN.0.45 MM X 13 MM SYRINGE WITH NEEDLE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 7018480

    Patients

    Seq Age Sex Outcome Treatment
    1 Other