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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Model Number 382634
Device Problem Material Perforation (2205)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: our quality engineer inspected the sample submitted for evaluation. Bd received one used retracted needle assembly, a used catheter adapter assembly, and an opened package. Upon inspection of the received unit, it was found that the tip of the catheter was bent. The reported defect was confirmed. Further inspection of the catheter revealed a v shape cut was present in the catheter tubing indicating the cannula tip had pierced the catheter wall. This type of damage would allow for the catheter to appear bent. A spear through may occur during manufacturing or in the user environment. If the spear through had occurred during manufacturing, the device would have been received with the catheter tip and cannula tip making a y shape which should have been noticed during tip adhesion break. In this state, venipuncture would likely be improbable. During use, a spear through may occur due to advancing the needle at the wrong angle or moving the needle up and down the catheter tubing during venipuncture. Media was present inside the catheter tubing and flashback chamber indicating that initial venipuncture was achieved; therefore, it was determined that the defect most likely originated during venipuncture. A device history record review showed no non-conformances associated with this issue during the production of this batch. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the cannula tip had pierced through the bd insyte¿ autoguard¿ bc shielded iv catheter wall, making the catheter tip appear bent. The following information was provided by the initial reporter: "(b)(6) 2021 (ed rn): in room to place iv. Attempted to place 20g to r wrist. Needle inserted, iv catheter would not advance. Iv dc¿d. Tip of catheter bent at top of catheter¿. " via bd investigation: "further inspection of the catheter revealed a v shape cut was present in the catheter tubing indicating the cannula tip had pierced the catheter wall. This type of damage would allow for the catheter to appear bent. ".
 
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Brand NameBD INSYTE AUTOGUARD BC SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12132948
MDR Text Key262410609
Report Number1710034-2021-00555
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Model Number382634
Device Catalogue Number382634
Device Lot Number9170992
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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