BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    MDR report key: 8479383 · Received April 3, 2019

    Report

    Report Number
    9614033-2019-00144
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    March 8, 2019
    Report Date
    May 2, 2019
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE SAMPLE AND PHOTO RECEIVED FOR INVESTIGATION. FOURIER TRANSFORM INFRARED SPECTROSCOPY ANALYSIS WAS COMPLETED ON THE MATERIAL OBSERVED IN THE BARREL OF THE SYRINGE. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. THE LOT WAS INSPECTED ACCORDING TO THE CURRENT WORK INSTRUCTION WITH SATISFACTORY RESULTS FOR THE CHARACTERISTICS REQUIRED FOR ITS APPROVAL INCLUDING FUNCTIONAL TESTS. NO NON-CONFORMING PART THAT COULD BE ATTRIBUTABLE TO THE DEFECT REPORTED BY THE CLIENT WAS PRESENTED. NO DEVIATIONS (QUALITY NOTIFICATIONS) WERE REPORTED DURING THE MANUFACTURING PROCESS. DURING THE DOCUMENTARY REVIEW OF THE BATCH RECORD NO PROBLEM WAS DETECTED ATTRIBUTABLE TO THE DEFECT REPORTED BY THE CLIENT, ADDITIONAL FUNCTIONAL TEST OF SILICONE CONTENT WAS FOUND WITHIN SPECIFICATION, WHEN PERFORMING THE TEST BY THE FRANKLIN LAB LAKES OF THE SAMPLE THIS PRESENTS SIGNS WITH SIMILARITIES TO THE SILICONE THAT IS USED TO LUBRICATE THE BODY OF THE CYLINDER, THIS COULD HAVE BEEN A PUNCTUAL CASE OF SURPLUS SILICONE IN NOZZLE SINCE MONTHLY IN THE CLEANING FOR EQUIPMENT OF MANUFACTURE IS MADE OF SURFACE WAY CLEANING IN SILICONE NOZZLES, ADDITIONAL HALF-YEARLY THE NOZZLES ARE DISASSEMBLED FOR DEEP CLEANING AS PART OF THE PREVENTATIVE MAINTENANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN, PLASTIC-LIKE PIECES WERE FOUND INSIDE THE BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. DESCRIPTION OF ISSUE: CUSTOMER REPORTS INSIDE OF SYRINGE THERE IS DEBRIS. CUSTOMER STATED IT LOOKED LIKE PLASTIC PIECES. 2. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 3. WHAT WAS YOUR BG READING AT THE TIME OF THIS EVENT? 143. 3. NUMBER OF OCCURRENCES: 1. 4. ITEM NUMBER . O CHOOSE ONE: ¿ 3 ML SYRINGE ¿ 309657. 5. PRODUCT LOT NUMBER: 8222920. 6. ARE SAMPLES AVAILABLE FOR INVESTIGATION? O YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)? YES. 7. DID ISSUE CAUSE ANY INJURY? IF YES, WHAT TYPE OF INJURY? NO. 8. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO.

    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, PLASTIC-LIKE PIECES WERE FOUND INSIDE THE BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION OF ISSUE: CUSTOMER REPORTS INSIDE OF SYRINGE THERE IS DEBRIS. CUSTOMER STATED IT LOOKED LIKE PLASTIC PIECES. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 3. WHAT WAS YOUR BG READING AT THE TIME OF THIS EVENT? 143. NUMBER OF OCCURRENCES: 1 ITEM NUMBER. CHOOSE ONE: 3 ML SYRINGE ¿ 309657. PRODUCT LOT NUMBER: 8222920. ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)? YES. DID ISSUE CAUSE ANY INJURY? IF YES, WHAT TYPE OF INJURY? NO. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273539 BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 8222920 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other