BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 18074062 · Received November 6, 2023

    Report

    Report Number
    1710034-2023-01255
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 12, 2023
    Report Date
    December 20, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 220 22GX1.00IN INSYTE AUTOGUARD DEVICES FROM LOT NUMBER 3192272. A GROSS VISUAL INSPECTION SHOWED THAT ALL THE UNITS ARE SEALED IN THEIR PACKAGING AND HAVE NO PHYSICAL DEFECTS. A SAMPLING OF 125 UNITS WERE RANDOMLY SELECTED TO BE TESTED. A PENETRATION AND DRAG TEST WAS PERFORMED. TWO UNITS FAILED THE CATHETER PENETRATION FORCE TEST. ALL 125 UNITS WERE FOUND WITHIN SPECIFICATION FOR THE NEEDLE PENETRATION FORCE AND DRAG TEST. THE REPORTED ISSUES WERE CONFIRMED. THE TWO FAILED UNITS WERE FURTHER INSPECTED UNDER A MICROSCOPE, AND IT WAS IDENTIFIED THAT THE CATHETER TIP ON BOTH UNITS WERE DAMAGED. ONE UNIT WAS FOUND TO HAVE SOME BUBBLES AND A ROUGH EDGE. THE SECOND UNIT HAD A ROUGH EDGE AND A FLASH, ROUND SHAPE AT THE TIP OF THE CATHETER WAS FOUND. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE. DURING MANUFACTURING, THIS MAY OCCUR DUE TO INCORRECT TEMPERATURE, INCORRECT TIPPING FORCE, MANDREL WORN OUT, DIRTY DIE AND/OR BENT MANDREL. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC CATHETER IS DEFECTIVE/DAMAGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: XXXX AT XXXXX CALLED STATING THAT THEY ARE HAVING A PROBLEMS WITH BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER STATING THAT THEY ARE HAVING TROUBLE INSERTING THE IV THEY SEEM TO HAVE A BUBBLE ON THEM AND ARE NOT STRAIGHT. PATIENTS HAVE TO BE POKED MULTIPLE TIMES. (B)(6) 2023 - ARE YOU ABLE TO RECONFIRM THE DATE OF EVENT WAS ON (B)(6) 2023? AND A WEEK PRIOR TO THAT AT RANDOM TIMES. - WHEN REFERRING TO "BUBBLE" ARE YOU SPEAKING OF A "BUBBLE" SHAPE ON THE OUTSIDE OF THE CATHETER OR AN AIR BUBBLE WITHIN THE CATHETER TUBING? OUTSIDE OF THE CATHETER, MAKING DIFFICULT TO ADVANCE INTO PATIENT AND ALSO INITIAL STICK INTO THE SKIN. - AS YOU STATED THE CATHETER IS NOT STRAIGHT, DOES THE NEEDLE APPEAR TO BE STRAIGHT? YES - HOW MANY OCCURRENCES OF DEFECTIVE SET(S) AFFECTED? (AIR BUBBLE, CATHETER NOT STRAIGHT, AND THREADING DIFFICULT) GUESSING 15-20 - WAS ISSUE BEING DESCRIBED NOTED BEFORE, OR DURING USED? DURING USE - ANY ADVERSE EVENTS OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO - WHAT WAS THE PATIENT OUTCOME? SEVERAL IV STICKS (B)(6) 2023 ¿ WAS THIS A SIGNIFICANT DELAY WHERE THE PROCEDURE HAD TO BE RESCHEDULED FOR A LATER TIME, OR A MINOR DELAY WHERE THE PROCEDURE CONTINUED AS SCHEDULED BUT JUST A SHORT TIME PASSED? THE PROCEDURE PROCEEDED AT A LATER TIME- 10-15 MIN LATE. ¿ WAS THERE A NEGATIVE IMPACT TO THE PATIENT DUE TO THE REPORTED DELAY? NO. THE CASE WENT WELL ¿ IT WAS ALSO STATED WHEN CLARIFYING THE EVENT DATE THAT "AND A WEEK PRIOR TO THAT AT RANDOM TIMES". DID ANY OF THESE OTHER EVENTS RESULT IN PATIENT HARM (CHANGE IN MEDICAL TREATMENT, SIGNIFICANT DELAYS IN TREATMENT, ADDITIONAL PROCEDURES OR DIAGNOSTICS) THAT RESULTED BECAUSE OF THE REPORTED EVENT? NO HARM TO PATIENT. JUST A FEW EXTRA NEEDLE STICKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154896 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3192272 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown