BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER 19X1-1/2 TW

    MDR report key: 8670531 · Received June 5, 2019

    Report

    Report Number
    1911916-2019-00562
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    February 8, 2019
    Report Date
    June 25, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052005
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION, THE DATE RECEIVED BY MANUFACTURER HAS BEEN UPDATED. THE FOLLOWING INFORMATION HAS BEEN UPDATED: DATE RECEIVED BY MANUFACTURER: 2019-06-03.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE (1) SAMPLE AND TWO (2) PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE RETURNED SAMPLE WAS VIEWED USING LIGHTED 40X MAGNIFICATION. THE FOREIGN MATTER (FM) WAS VISUALLY IDENTIFIED AS CLEAR PLASTIC ON THE NEEDLE. TWO (2) PHOTOS WERE ALSO PROVIDED BY THE CUSTOMER. THE TWO (2) PHOTOS SHOW A WHITE PARTICLE ON THE STOPPER IN A SYRINGE FILLED WITH LIQUID. THE NEEDLE HUB FILTER WAS EXAMINED AND NO WHITE PARTICLES WERE FOUND ON THE FILTER NOR WAS ANYTHING FOUND TO BE IN THE ENVELOPE IN WHICH THE SAMPLE WAS RETURNED. THE SMALL CLEAR PLASTIC PARTICLE COULD BE FROM COMPONENTS FROM THE MACHINERY USED IN THE ASSEMBLY AND PACKAGING PROCESS. 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 DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. CONCLUSION: THE SMALL CLEAR PLASTIC PARTICLE COULD BE FROM COMPONENTS FROM THE MACHINERY USED IN THE ASSEMBLY AND PACKAGING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE FILTER 19X1-1/2 TW EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305200. LOT NUMBER: 7290803. ORIGINAL EMAIL: QA (COMPLAINTS) HAS RECEIVED A PRODUCT COMPLAINT RELATED TO A FOREIGN MATTER OBSERVATION IN ONE SYRINGE AFTER DOSE WITHDRAWAL. PER REPORTER, ON (B)(6) 2019, THE REPORTER CONTACTED DISTRIBUTOR VIA PHONE TO REQUEST REPLACEMENT OF 1 VIAL OF MEDICATION BECAUSE THERE IS A GRAY/WHITE PARTICLE IN THE SOLUTION OF THE SYRINGE. THE REPORTER BELIEVES THAT IT IS A PART OF THE FILTER NEEDLE THAT WAS DEFECTIVE. THE REPORTER DENIED ANY ADVERSE EVENTS OR MISSED DOSES DUE TO THIS EVENT. BD COMPONENT LOT AFFECTED: BD 1 ML SYRINGE CATALOG NUMBER: 309628. LOT NUMBER: 5112913. PLEASE NOTE: THE RETUNED SYRINGE WAS SENT TO DISTRIBUTOR FOR ID TESTING AS THE FM WAS SUSPECTED TO BE STOPPER CORING, HOWEVER, THE QC TESTING FOUND THE FOLLOWING: THE BEST MATCHES OBTAINED WERE POLYVINYLCHLORIDE, HIGHLY SOFTENED FOAM WHITE, AND FILLED POLYMER USED AS 220V WIRE INSULATION. POLYVINYLCHLORIDE IS THERMOPLASTIC POLYMER COMPOSED OF SYNTHETIC RESIN AND FILLED POLYMER IS A POLYMER COMPOSITE USED IN ELECTRICAL INSULATION (E.G. CABLE COATING). MAY BE A FABRIC THAT IS COMPOSED OF POLYETHER AND POLYESTER COPOLYMER. BASED ON THE VISUAL OBSERVATION, SIMILARITY SEARCH, AND COMPARISON OF THE FOREIGN MATTER SPECTRUM WITH THE MEDICATION VIAL RUBBER STOPPER SPECTRA FROM THE DISTRIBUTOR COMPLAINT LIBRARY, THE FOREIGN MATTER IS MOST LIKELY TO BE A POLYMER-BASED MATERIAL, WHICH IS NOT LIKELY TO HAVE BEEN INTRODUCED FROM THE MEDICATION VIAL RUBBER STOPPER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE FILTER 19X1-1/2 TW EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305200. LOT NUMBER: 7290803. ORIGINAL EMAIL: QA (COMPLAINTS) HAS RECEIVED A PRODUCT COMPLAINT RELATED TO A FOREIGN MATTER OBSERVATION IN ONE SYRINGE AFTER DOSE WITHDRAWAL. PER REPORTER, ON (B)(6) 2019, THE REPORTER CONTACTED DISTRIBUTOR VIA PHONE TO REQUEST REPLACEMENT OF 1 VIAL OF MEDICATION BECAUSE THERE IS A GRAY/WHITE PARTICLE IN THE SOLUTION OF THE SYRINGE. THE REPORTER BELIEVES THAT IT IS A PART OF THE FILTER NEEDLE THAT WAS DEFECTIVE. THE REPORTER DENIED ANY ADVERSE EVENTS OR MISSED DOSES DUE TO THIS EVENT. BD COMPONENT LOT AFFECTED: BD 1 ML SYRINGE CATALOG NUMBER: 309628. LOT NUMBER: 5112913. PLEASE NOTE: THE RETUNED SYRINGE WAS SENT TO DISTRIBUTOR FOR ID TESTING AS THE FM WAS SUSPECTED TO BE STOPPER CORING, HOWEVER, THE QC TESTING FOUND THE FOLLOWING: THE BEST MATCHES OBTAINED WERE POLYVINYLCHLORIDE, HIGHLY SOFTENED FOAM WHITE, AND FILLED POLYMER USED AS 220V WIRE INSULATION. POLYVINYLCHLORIDE IS THERMOPLASTIC POLYMER COMPOSED OF SYNTHETIC RESIN AND FILLED POLYMER IS A POLYMER COMPOSITE USED IN ELECTRICAL INSULATION (E.G. CABLE COATING). MAY BE A FABRIC THAT IS COMPOSED OF POLYETHER AND POLYESTER COPOLYMER. BASED ON THE VISUAL OBSERVATION, SIMILARITY SEARCH, AND COMPARISON OF THE FOREIGN MATTER SPECTRUM WITH THE MEDICATION VIAL RUBBER STOPPER SPECTRA FROM THE DISTRIBUTOR COMPLAINT LIBRARY, THE FOREIGN MATTER IS MOST LIKELY TO BE A POLYMER-BASED MATERIAL, WHICH IS NOT LIKELY TO HAVE BEEN INTRODUCED FROM THE MEDICATION VIAL RUBBER STOPPER.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE FILTER 19X1-1/2 TW EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305200, LOT NUMBER: 7290803. ORIGINAL EMAIL: QA (COMPLAINTS) HAS RECEIVED A PRODUCT COMPLAINT RELATED TO A FOREIGN MATTER OBSERVATION IN ONE SYRINGE AFTER DOSE WITHDRAWAL. PER REPORTER, ON (B)(6) 2019, THE REPORTER CONTACTED DISTRIBUTOR VIA PHONE TO REQUEST REPLACEMENT OF 1 VIAL OF MEDICATION BECAUSE THERE IS A GRAY/WHITE PARTICLE IN THE SOLUTION OF THE SYRINGE. THE REPORTER BELIEVES THAT IT IS A PART OF THE FILTER NEEDLE THAT WAS DEFECTIVE. THE REPORTER DENIED ANY ADVERSE EVENTS OR MISSED DOSES DUE TO THIS EVENT. BD COMPONENT LOT AFFECTED: BD 1 ML SYRINGE CATALOG NUMBER: 309628, LOT NUMBER: 5112913. PLEASE NOTE: THE RETUNED SYRINGE WAS SENT TO DISTRIBUTOR FOR ID TESTING AS THE FM WAS SUSPECTED TO BE STOPPER CORING, HOWEVER, THE QC TESTING FOUND THE FOLLOWING: THE BEST MATCHES OBTAINED WERE POLYVINYLCHLORIDE, HIGHLY SOFTENED FOAM WHITE, AND FILLED POLYMER USED AS 220V WIRE INSULATION. POLYVINYLCHLORIDE IS THERMOPLASTIC POLYMER COMPOSED OF SYNTHETIC RESIN AND FILLED POLYMER IS A POLYMER COMPOSITE USED IN ELECTRICAL INSULATION (E.G. CABLE COATING). MAY BE A FABRIC THAT IS COMPOSED OF POLYETHER AND POLYESTER COPOLYMER. BASED ON THE VISUAL OBSERVATION, SIMILARITY SEARCH, AND COMPARISON OF THE FOREIGN MATTER SPECTRUM WITH THE MEDICATION VIAL RUBBER STOPPER SPECTRA FROM THE DISTRIBUTOR COMPLAINT LIBRARY, THE FOREIGN MATTER IS MOST LIKELY TO BE A POLYMER-BASED MATERIAL, WHICH IS NOT LIKELY TO HAVE BEEN INTRODUCED FROM THE MEDICATION VIAL RUBBER STOPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462767 NEEDLE FILTER 19X1-1/2 TW MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 7290803 30382903052005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other