BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 23G 1-1/4IN TW

    MDR report key: 8890859 · Received August 13, 2019

    Report

    Report Number
    8041187-2019-00627
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Date of Event
    July 24, 2019
    Report Date
    September 18, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY DHR FOR ASSEMBLED NEEDLE (AN) WAS PERFORMED FOR BATCH 8010340, 8010339, 7361266, 7361265 (CATALOG N00142SGT) ¿ BATCH 8010340, 7361266, 7361265 WERE BUILT WITH ASSEMBLY MACHINE, NIP 1 IN JAN 2018. ¿ BATCH 8010339 WAS BUILT WITH ASSEMBLY MACHINE, NIP 3 IN JAN 2018. ¿ THERE WERE NO FOREIGN MATTER REJECTS AT THE OUTGOING INSPECTION. ¿ NO QUALITY NOTIFICATION WAS RAISED FOR PAST 12 MONTHS ON SIMILAR REPORTED DEFECT. DHR FOR PACKAGED NEEDLE (PN) WAS PERFORMED FOR BATCH 8010347 (CATALOG 302008) ¿ THE BATCH WAS BUILT WITH PACKAGING MACHINE IN JAN 2018. ¿ NO QUALITY NOTIFICATION WAS RAISED FOR PAST 12 MONTHS ON SIMILAR REPORTED DEFECT. VISUAL INSPECTION ¿ ALL 385 SAMPLES WERE SUBJECTED TO VISUAL INSPECTION TO CHECK FOR FOREIGN MATTER. ¿ 9 OUT OF 385 SAMPLES WERE OBSERVED WITH BLACK/BROWN FOREIGN MATTER INSIDE THE PACKAGE (REFER TO FIGURE 2). ¿ THE FOREIGN MATTER WAS OBSERVED TO BE A FORM OF STAIN IN-BETWEEN THE BOTTOM WEB AND TOP WEB. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS: ¿ THE FOREIGN MATTER WAS SENT FOR THE FTIR TEST TO DETERMINE THE FOREIGN MATTER TYPE. ¿ THE FTIR RESULTS SHOWS THAT THE SPECTRUM MATCHES REASONABLY WITH THAT OF ETHYLENE VINYL ACETATE AND OTHER UNKNOWN COMPOUNDS. ¿ ETHYLENE VINYL ACETATE IS A TYPE OF ELASTIC POLYMER AND NORMALLY USED IN ADHESIVES, SEALANTS, AND COATINGS. ABLE TO CONFIRM THE CUSTOMER EXPERIENCE BASED ON THE SAMPLE EVALUATION. CONCLUSION: BASED ON THE FTIR RESULTS, THE FOREIGN MATTER SPECTRUM MATCH REASONABLY WITH ETHYLENE VINYL ACETATE AND OTHER UNKNOWN COMPOUNDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS DISCOVERED WITH A BD NEEDLE 23G 1-1/4IN TW. THIS OCCURRED ON 100 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER FOUND A BOX OF NEEDLES THAT HAD BLACK SPOTS/DEBRIS INSIDE THE STERILE PACKAGING.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS DISCOVERED WITH A BD NEEDLE 23G 1-1/4IN (B)(4). THIS OCCURRED ON 100 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER FOUND A BOX OF NEEDLES THAT HAD BLACK SPOTS/DEBRIS INSIDE THE STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684101 BD NEEDLE 23G 1-1/4IN TW NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 8010347

    Patients

    Seq Age Sex Outcome Treatment
    1 Other