BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGUARD3 SAFETY

    MDR report key: 5488613 · Received March 9, 2016

    Report

    Report Number
    3003902955-2016-00009
    Event Type
    Malfunction
    Date Received
    March 9, 2016
    Report Date
    March 9, 2016
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN FOR THIS COMPLAINT. BASED ON THE CUSTOMER'S SALES HISTORY, THE FOLLOWING IS A POTENTIAL PRODUCT CODE AND LOT NUMBER AND EXPIRATION DATE: (1) SS-03L, LOT # 150616K AND EXPIRATION DATE: 05/31/2020. THE ACTUAL SAMPLE WAS NOT RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION AND THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. THEREFORE, THE INVESTIGATION WAS BASED ON EVALUATION OF USER FACILITY INFORMATION AND RETENTION SAMPLES OF THE ABOVE STATED POTENTIAL PRODUCT/LOT COMBINATION. VISUAL INSPECTION REVEALED NO DEFECTS. PACKAGING OF ALL RETENTIONS SAMPLES MET MANUFACTURING SPECIFICATION. OUR LUBRICANT IS MADE FROM NON-REACTING SILICON, AS PER ISO 7886-1. THE POTENTIAL SYRINGE LOT WAS TESTED FOR ENDOTOXIN THRU LIMULUS AMEBOCYTE LYSATE TEST TO CHECK PRESENCE OF BACTERIAL ENDOTOXIN ON FINISHED PRODUCTS AND MET SPECIFICATION FOR ENDOTOXIN LIMIT FOR MEDICAL DEVICES. IN ADDITION, QC PERFORMS MONTHLY CHECKS OF THE PHYSICAL AND CHEMICAL PROPERTIES OF THE STERILE SYRINGE THROUGH THE PHYSICOCHEMICAL TEST. TEST ITEMS INCLUDE TEST FOR ACIDITY/ALKALINITY AND TRACES OF METALS SUCH AS CADMIUM, LEAD, IRON, ZINC AND TIN. BASED ON RECORDS, THE POTENTIALLY AFFECTED LOTS ALL PASSED. OUR PRODUCTS COMPLY WITH ISO 10993-1; BIOLOGICAL EVALUATION FOR MEDICAL DEVICES. ALSO, ALL FINISHED PRODUCT ARE STERILIZED PRIOR TO SHIPMENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE POTENTIAL LOTS WAS CONDUCTED WITH NO RELEVANT FINDINGS. PRIOR TO SHIPMENT, QC CONDUCTS OUTGOING VISUAL INSPECTION AND ALL SAMPLES FOR THE POTENTIAL COMPLAINT LOT PASSED. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION AND THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION FROM THE USER FACILITY AND INVESTIGATION RESULTS. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO (PHILIPPINES) CORPORATION (MANUFACTURER) REGISTRATION NO. 3003902955. EXEMPTION NUMBER E2015017. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER

    Description of Event or Problem · 0

    AN UNKNOWN ASSISTANT FOR A PHYSICIAN REPORTED THE FOLLOWING: A PATIENT OF AN UNKNOWN AGE AT TIME OF DEATH STARTED ABILIFY MAINTENA 400MG EVERY 4 WEEKS ON (B)(6) 2015 FOR UNSPECIFIED SCHIZOPHRENIA; THE PATIENT'S MEDICAL HISTORY, CONCOMITANT MEDICATIONS, AND PAST DRUG HISTORY ARE UNKNOWN; IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT EXPIRED; THE DATE OF DEATH AND CAUSE OF DEATH ARE UNKNOWN; THE PATIENT'S RELEVANT LABORATORY DATA ARE UNKNOWN; AND AS OF (B)(6) 2016, THE PATIENT NO LONGER TAKES ABILIFY MAINTENA BECAUSE THE PATIENT EXPIRED. NEITHER THE ABILIFY MAINTENA DUAL CHAMBER SYRINGE NOR ANY OF ITS COMPONENTS WERE DIRECTLY IMPLICATED IN THIS COMPLAINT HOWEVER TERUMO IS REPORTING THIS ISSUE OUT OF AN ABUNDANCE OF CAUTION AND DUE DILIGENCE. ALL POTENTIALLY RELATED LOTS ARE BEING FULLY INVESTIGATED.

    Additional Manufacturer Narrative · 1

    AS STATED, THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 FOR MFG. REPORT NO. 3003902955-2016-00009 TO STATE IT HAS BEEN DETERMINED THAT ALTHOUGH THIS COMPLAINT WAS SENT OUT OF AN ABUNDANCE OF CAUTION AND DUE DILIGENCE, THE REPORTED COMPONENTS MANUFACTURED BY TMC ARE NOT IMPLICATED IN THIS COMPLAINT. THEREFORE, THE MDR IS BEING CANCELED.

    Additional Manufacturer Narrative · 1

    AS STATED, THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP #1 FOR MFG. REPORT 3003902955-2016-00009 TO PROVIDE EVALUATION RESULTS FOR THE ADDITIONAL POTENTIAL LOTS REPORTED. THE PRODUCT CODE AND LOT NUMBER IS UNKNOWN FOR THIS COMPLAINT. THE FOLLOWING ARE LOT NUMBERS AND EXPIRATION DATES FOR LOTS POTENTIALLY INVOLVED IN THE REPORTED COMPLAINT BASED ON THE DISTRIBUTION RECORDS: LOT NUMBER/EXPIRATION DATE: 150513A / 02-29-2020, 141125C / 10-31-2019. BASED ON THE MANUFACTURING RECORDS, THE FOLLOWING ARE EQUIVALENT CODES THAT WERE DISTRIBUTED TO THE CUSTOMER: (B)(4). THE ACTUAL SAMPLE WAS NOT RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION AND THE PRODUCT CODE AND LOT NUMBER IS UNKNOWN. THEREFORE, THE INVESTIGATION WAS BASED ON EVALUATION OF USER FACILITY INFORMATION AND RETENTION SAMPLES OF THE ABOVE STATED POTENTIAL PRODUCT/LOT COMBINATIONS. VISUAL INSPECTION REVEALED NO DEFECTS. THE COATING OF SILICONE WAS CONFIRMED TO BE PRESENT AND ALL SAMPLES MET MANUFACTURING SPECIFICATIONS. PACKAGING OF ALL RETENTIONS SAMPLES MET MANUFACTURING SPECIFICATIONS. NEEDLE PENETRATION OF ALL RETENTIONS SAMPLES WERE TESTED AND MET MANUFACTURER SPECIFICATIONS. THE CANNULA IS MADE UP OF STAINLESS STEEL AND HAD UNDERGONE TESTING FOR STIFFNESS AND BEND RESISTANCE. THE SUPPLIED CANNULA FOR THESE LOTS WERE INVESTIGATED AND CONFIRMED NO NON CONFORMITIES THAT MAY HAVE LED TO THE REPORTED COMPLAINT. THE CANNULA IS COMPLIANT AS PER ISO 9626 REGARDING STIFFNESS OF THE STAINLESS TUBING. OUR LUBRICANT IS MADE FROM NON-REACTING SILICON, AS PER ISO 7864. EACH LOT WAS TESTED FOR ENDOTOXIN THRU LIMULUS AMEBOCYTE LYSATE TEST TO CHECK PRESENCE OF BACTERIAL ENDOTOXIN ON FINISHED PRODUCTS AND MET SPECIFICATION FOR ENDOTOXIN LIMIT FOR MEDICAL DEVICES. IN ADDITION, QC PERFORMS MONTHLY CHECKS OF THE PHYSICAL AND CHEMICAL PROPERTIES OF THE STERILE PRODUCTS PER NEEDLE GAUGE THROUGH THE PHYSICOCHEMICAL TEST. TEST ITEMS INCLUDE TEST FOR ACIDITY/ALKALINITY AND TRACES OF METALS SUCH AS CADMIUM, LEAD, IRON, ZINC AND TIN. BASED ON RECORDS, THE POTENTIALLY AFFECTED LOTS ALL PASSED. OUR PRODUCTS COMPLY WITH ISO 10993-1; BIOLOGICAL EVALUATION FOR MEDICAL DEVICES. ALSO, ALL FINISHED PRODUCT ARE STERILIZED PRIOR TO SHIPMENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE POTENTIAL LOTS WAS CONDUCTED WITH NO RELEVANT FINDINGS. PRIOR TO SHIPMENT, QC CONDUCTS OUTGOING VISUAL INSPECTION AND ALL SAMPLES FOR THE COMPLAINT LOTS PASSED. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION AND THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION FROM THE USER FACILITY AND INVESTIGATION RESULTS. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 FOR MFG. REPORT NO. 3003902955-2016-00009 TO STATE IT HAS BEEN DETERMINED THAT ALTHOUGH THIS COMPLAINT WAS SENT OUT OF AN ABUNDANCE OF CAUTION AND DUE DILIGENCE, THE REPORTED COMPONENTS MANUFACTURED BY TMC ARE NOT IMPLICATED IN THIS COMPLAINT. THEREFORE, THE MDR IS BEING CANCELED.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP #1 FOR MFG. REPORT 3003902955-2016-00009 TO PROVIDE EVALUATION RESULTS FOR THE ADDITIONAL POTENTIAL LOTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146362 SURGUARD3 SAFETY SYRINGE MEG TERUMO PHILIPPINES CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ABILIFY MAINTENA KIT W/ TERUMO SG3+NEEDLES