BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML W/O

    MDR report key: 8876057 · Received August 8, 2019

    Report

    Report Number
    2243072-2019-01644
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    July 24, 2019
    Report Date
    September 13, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATIONS: 240 SAMPLES WERE RETURNED TO SBDM, LOT NUMBER IS 1901214. COMPLAINT SAMPLES LEAKAGE TEST: SBDM CONDUCTED LEAKAGE TEST ON THE 240 SAMPLES AND RESULTS ARE: - WHEN PULLED STRAIGHT, THE SYRINGES SHOW NO LEAKAGE OR AIR ASPIRATION. - WHEN PULLED OBLIQUELY, THE SYRINGES SHOW NO LEAKAGE OR AIR ASPIRATION. COMPLAINT SAMPLES NEEDLE LEAK TEST: - WHEN PULLED STRAIGHT, THE NEEDLES SHOW NO LEAKAGE. - WHEN PULLED OBLIQUELY, THE NEEDLES SHOW NO LEAKAGE. LEAKAGE TEST BY AIR PRESSURE: SBDM CONDUCTED LEAK TEST OF THE COMPLAINT SAMPLES RECEIVED BY AIR PRESSURE UNDER 0.72MPA, THERE WAS NO LEAKAGE COMPLAINT SAMPLES. DIMENSION MEASUREMENT: FOR THE 10 COMPLAINT SAMPLES, SBDM MEASURED THE INTERNAL DIAMETER OF BARREL AND OUTER DIAMETER OF STOPPER. THE RESULTS SHOWS THE DIMENSION ARE WITHIN SPECIFICATIONS. BARREL INTERNAL DIAMETER: SPEC F20.05 +/- 0.05MM. 10 SAMPLES WERE MEASURED AND WITHIN SPECIFICATIONS. STOPPER OUTER DIAMETER: SPEC F21.0 + 0.05MM. SAMPLES WERE MEASURED AND WITHIN SPECIFICATIONS. LEAK TEST RESULTS BY DIFFERENT BATCH OF STOPPER RAW MATERIAL: SBDM CONDUCTED THE LEAKAGE TEST OF 1,500 SAMPLES IN EACH DIFFERENT BATCH OF STOPPER RAW MATERIAL, AFTER ALL MANUFACTURING PROCESS WAS FINISHED INCLUDED STERILIZATION. THERE WAS NO LEAKAGE IN A RAW MATERIAL LOT NO. 20190304-1 BUT, 2 LEAKAGE SAMPLE WERE FOUND IN A RAW MATERIAL LOT NUMBER 20190311-1 HOUSE SAMPLE INSPECTION: SBDM INSPECTED 20 PCS HOUSE SAMPLES FROM LOTS 1901214 AND 1902202, NO ABNORMALITY WAS OBSERVED. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 1901214), NO ABNORMALITY OBSERVED. CUSTOMER COMPLAINT RECORD: SBDM REVIEWED THE CUSTOMER COMPLAINT RECORD, THERE WERE SIMILAR ISSUES FROM OTHER CUSTOMERS. ROOT CAUSE: FROM INVESTIGATION, SBDM COULD NOT FIND AIR ASPIRATION IN THE COMPLAINT SAMPLES. SBDM INDICATE POSSIBILITY OF STOPPER RAW MATERIAL SPECIFICATION BEING WIDE THAT CAUSE THE COMPLAINT CASE. THE STOPPER INJECTION CONDITION SHOULD BE CHANGED ACCORDING TO THE STOPPER RAW MATERIAL BATCH CHANGED BUT LINE WORKERS KEPT THE BEST INJECTION CONDITION THAT THEY FOUND BEFORE. SBDM WILL REQUEST TO RAW MATERIAL SUPPLIER TO MEET THE SPEC SIMILAR WITH RAW MATERIAL LOT NO. 20190304-1 THAT WAS TESTED WITH NO LEAKAGE USING CURRENT INJECTION CONDITION OF THE BARREL BY SBDM. ALSO, USING STOPPER RAW MATERIAL LOT NO. 20190311-1 SBDM FOUND 2 LEAKAGE SAMPLES WITH CURRENT INJECTION CONDITION. SBDM WILL TRY TO FIND THE BEST INJECTION CONDITION FOR THE BARREL TO MATCH THE STOPPER. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 20 SYRINGE 20ML W/O EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS LEAKAGE OF FLUID TO BACKWARD. THEREFORE, THE CUSTOMER DISCARDED ANTICANCER DRUG. ADDITIONAL INFO: 1.WAS THERE ANY SKIN CONTACT DUE TO ANTICANCER DRUG LEAKAGE FLUID BACKWARD? ¿ THERE WAS NO SKIN CONTACT. 2.WHO IS THE HEALTHCARE PROVIDER ENCOUNTERED THIS INCIDENT? ¿ PHARMACIST

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 20 SYRINGE 20ML W/O EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS LEAKAGE OF FLUID TO BACKWARD. THEREFORE, THE CUSTOMER DISCARDED ANTICANCER DRUG. ADDITIONAL INFO: WAS THERE ANY SKIN CONTACT DUE TO ANTICANCER DRUG LEAKAGE FLUID BACKWARD? THERE WAS NO SKIN CONTACT. WHO IS THE HEALTHCARE PROVIDER ENCOUNTERED THIS INCIDENT? PHARMACIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671188 SYRINGE 20ML W/O SYRINGE FMF BECTON DICKINSON 1901214

    Patients

    Seq Age Sex Outcome Treatment
    1 Other