BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD

    MDR report key: 8828696 · Received July 25, 2019

    Report

    Report Number
    1710034-2019-00791
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    July 3, 2019
    Report Date
    September 4, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814344
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. RECEIVED A TOTAL OF (B)(4) IAG 20GA UNITS AS FOLLOWS: LOT #9007814: (B)(4) UNITS RECEIVED WITHIN SEALED PACKAGES AND 3 INSIDE AN OPEN PACKAGE. LOT #8253636: (B)(4) UNITS RECEIVED WITHIN SEALED PACKAGES. VISUAL EVALUATION: 9007814: OPEN UNITS: HVS GEL WAS PRESENT IN THE SPRING CAVITY. SMALL AMOUNTS OF HVS GEL WERE OBSERVED ON THE NEEDLE COVER, ON THE OUTER LUER THREAD OF THE ADAPTER AND ON THE GRIP OF THE ASSEMBLY. HVS GEL WAS NOT OBSERVED ON THE CATHETER TUBING. 9007814 & 8253936: SEALED UNITS: HVS GEL WAS PRESENT IN THE SPRING CAVITY. HVS GEL WAS NOT OBSERVED ON THE CATHETER TUBING OR EXTERNAL TO THE SPRING CAVITY OF THE GRIP. FTIR ANALYSIS OF THE MATERIAL ON THE SURFACE OF THE CANNULA AND CATHETER WAS CONFIRMED TO HAVE THE SAME PROFILE AS DOW CORNING 360 MEDICAL FLUID. THIS INDICATES THE MATERIAL ON THE CATHETER IS THE CORRECT SILICONE LUBE AND NOT HVS GEL, BECAUSE DOW CORNING 360 MEDICAL FLUID AND THE SILICONE LUBE USED ON THE PRODUCT ARE BOTH POLYDIMETHYLSILOXANES. HVS GEL CONTAINS SILICONE DIOXIDE, WHICH WAS NOT EVIDENT IN THE FTIR ANALYSIS OF THE MATERIAL ON THE SURFACE OF THE CANNULA AND CATHETER. PHOTO EVALUATION: CUSTOMER PROVIDED TWO CLOSE-UP PHOTOGRAPHS OF THE CANNULA AND CATHETER: ONE SHOWS THE NEEDLE BEVEL AND THE SECOND SHOWS THE PROFILE OF THE NEEDLE TIP. THERE IS SOME VISIBLE SURFACE VARIATION IN THE PHOTOS DUE TO FLUCTUATING SILICONE LUBE THICKNESS ACROSS THE NEEDLE SURFACE. THIS IS A NORMAL APPEARANCE OF THE SILICONE LUBE THAT IS APPLIED TO THE NEEDLE AND CATHETER TO MINIMIZE FRICTIONAL FORCES WHILE INSERTING NEEDLE AND CATHETER INTO THE VASCULATURE. CONCLUSION: INVESTIGATION DID NOT CONFIRM HVS GEL LEAKING OUT FROM THE SPRING TO THE CATHETER TUBING; HOWEVER SMALL AMOUNTS OF THE HVS GEL WERE OBSERVED ON THE NEEDLE COVER, OUTER PORTION OF THE ADAPTER AND OUTSIDE OF THE GRIP OF THE RETURNED SAMPLES THAT HAD BEEN REMOVED FROM UNIT PACKAGES. THE NEEDLE COVER IS DESIGNED WITH AN INNER RIB THAT ALIGNS WITH THE HOLE IN THE GRIP WHERE HVS GEL IS INSERTED TO THE SPRING. IF THERE IS EXCESS HVS GEL OUTSIDE OF THE GRIP, IT CAN CONTACT THE RIB OF THE NEEDLE COVER. THEN WHEN THE NEEDLE COVER IS REMOVED FROM THE GRIP, THE HVS GEL CAN BE TRANSFERRED FROM THE NEEDLE COVER TO ANOTHER COMPONENT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD HAS BEEN FOUND EXPERIENCING TWO INSTANCES OF EXCESSIVE LUBRICANT IN/ON THE DEVICE BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381434, BATCH NO.: 9007814 & 8253936. IT WAS REPORTED THAT EXCESSIVE LUBRICANT FROM INSIDE THE SPRING HOUSING IS LEAKING OUT ON TO THE CATHETER. COMPLAINT 1 OF 2: EVENT DATE (B)(6) 2019. PHONE CALL ON (B)(6) 2019: SPOKE WITH CUSTOMER WHO PROVIDED CAT # 381434, LOTS 9007814 & 8253936. IT WAS EXPLAINED THAT THERE WAS EXCESSIVE LUBRICANT INSIDE NEAR THE SPRING THAT WAS LEAKING ONTO THE ANGIOCATH PART AS IT WAS FOUND IN THE PACKAGE. THEY HAVE 2 BOXES THEY PULLED, WOULD LIKE REPLACED, CAN SEND IN. 2 FOUND ON (B)(6) 2019, 2 MORE ON (B)(6) 2019, 1 FROM EACH LOT.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8253936, MEDICAL DEVICE EXPIRATION DATE: 2021-08-31, DEVICE MANUFACTURE DATE: 2018-09-10. MEDICAL DEVICE LOT #: 9007814, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2019-01-07. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD HAS BEEN FOUND EXPERIENCING TWO INSTANCES OF EXCESSIVE LUBRICANT IN/ON THE DEVICE BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381434 BATCH NO.: 9007814 & 8253936 IT WAS REPORTED THAT EXCESSIVE LUBRICANT FROM INSIDE THE SPRING HOUSING IS LEAKING OUT ON TO THE CATHETER. COMPLAINT 1 OF 2: EVENT DATE (B)(6) 2019. PHONE CALL ON 7/9/2019: SPOKE WITH CUSTOMER WHO PROVIDED CAT # 381434 LOTS 9007814 & 8253936. IT WAS EXPLAINED THAT THERE WAS EXCESSIVE LUBRICANT INSIDE NEAR THE SPRING THAT WAS LEAKING ONTO THE ANGIOCATH PART AS IT WAS FOUND IN THE PACKAGE. THEY HAVE 2 BOXES THEY PULLED, WOULD LIKE REPLACED, CAN SEND IN. 2 FOUND ON (B)(6) 2019, 2 MORE ON (B)(6) 2019, 1 FROM EACH LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623237 20G X 1.16IN (1.1 X 30 MM) INSYTE AUTOGUARD INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 30382903814344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other