BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML ALLERGIST TRAY WITH 27 G X 1/2 IN. BD SAFETYGLIDE¿

    MDR report key: 6904176 · Received September 29, 2017

    Report

    Report Number
    1920898-2017-00210
    Event Type
    Malfunction
    Date Received
    September 29, 2017
    Date of Event
    September 6, 2017
    Report Date
    November 13, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    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. . DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 7072717 INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) BD 1ML, 13MM, 27G SAFETYGLIDE ALLERGY SYRINGE WITH THE TRAY COVER FROM LOT # 7072717. CUSTOMER STATES THAT THE SYRINGE BARREL IS DARK GRAY. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED ONE SIDE OF THE BARREL COMPLETELY DARKENED DOWN THE LENGTH OF THE SURFACE OF THE BARREL. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SUGGESTS THAT THIS MATERIAL HAS COMPONENTS SIMILAR TO THOSE OF THE SCALE PRINT MATERIAL. SEE ATTACHED PHOTOS AND SPECTRA. SAMPLE WILL BE FORWARDED TO MANUFACTURING ((B)(4)) ON 29SEP2017 FOR FURTHER INVESTIGATION. UPON COMPLETION OF THE SECONDARY INVESTIGATION, A SECOND SUPPLEMENTAL REPORT WILL BE FILED. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE INVESTIGATION CONCLUSION: BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. RATIONALE: BASED ON THE INVESTIGATION, NO CAPA IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    SUMMARY INVESTIGATION: BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A. MINERVINO 29SEP2017. INVESTIGATION RECEIVED FROM MANUFACTURING SITE ((B)(4)): ON 03OCT2017, (B)(4) RECEIVED ONE (1) 1ML, 1/2IN, 27G SAFETYGLIDE SYRINGE WITH TYVEK ALLERGIST TRAY LABEL FROM BATCH# 7072717. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO EVALUATION. UPON EVALUATION BY (B)(4), IT WAS NOTED THAT THE ENTIRETY OF THE PRINT AREA ON THE BARREL WAS ESSENTIALLY 'BLACKED OUT'. PROCESS SPECIALIST, (B)(6), WAS CONSULTED AND PROVIDED THAT THE PROBABLE ROOT CAUSE WAS THAT THE PAD ON THE PRINTER WAS COVERED IN INK AT THE TIME THAT THIS SYRINGE WAS BEING MANUFACTURED. WHEN THIS OCCURS, YOU WILL SEE SCALE MARKINGS, SIMILAR TO THESE. REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #7072717. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] FOR SCRATCHED PRINT NOTED FOR ANY RELATED DEFECTS DURING THE PRODUCTION OF THESE BATCHES. THE (B)(4) PLANT IS CURRENTLY EVALUATING CONTINUOUS IMPROVEMENT PROJECTS TO HELP IMPROVE PRINT SCALE DEFECTS SEEN WITHIN THE FIELD. NO ADDITIONAL ACTIONS AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE 1 ML BD¿ ALLERGY SYRINGE W/27 G X 1/2 IN. NEEDLE HAD DARK GRAY FOREIGN MATTER IN THE BARREL. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683697 1 ML ALLERGIST TRAY WITH 27 G X 1/2 IN. BD SAFETYGLIDE¿ SYRINGE MEG BD MEDICAL - DIABETES CARE 7072717

    Patients

    Seq Age Sex Outcome Treatment
    1 Other