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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¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381934
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2021
Event Type  malfunction  
Event Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter hub was defective and partially separated from the catheter. The following information was provided by the initial reporter, translated from (b)(6) to english: "one autogard 20g catheter kinked in its packaging and not used. " via bd investigation: "upon inspection of the received unit, it was identified that neither the catheter or needle were bent but the hub was bent inside the grip. The defect of component damage was confirmed. The hub was then removed from the grip and barrel assembly for further inspection revealing that the hub had been bent resulting in it partially separating causing the catheter to appear bent. ".
 
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Date received by manufacturer: bd was initially made aware of this complaint on (b)(6) 2021. At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident. Additional information was later received on 2021-10-27 that changed the reportability determination. Based on the additional information received, this complaint is now considered to be an mdr reportable incident. Investigation summary: our quality engineer inspected the sample submitted for evaluation. Upon inspection of the received unit, it was identified that neither the catheter or needle were bent but the hub was bent inside the grip. The defect of component damage was confirmed. The hub was then removed from the grip and barrel assembly for further inspection revealing that the hub had been bent resulting in it partially separating causing the catheter to appear bent. The defect was determined to have occurred during the manufacturing/ packaging process, most likely having occurred prior the sealing of the package and after the catheter was placed. Operators perform function testing and visual inspections for damage or bent needles throughout the manufacturing process to mitigate the risk from this type defect. 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 and we appreciate you taking the time to bring this observation to our attention. 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.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ 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 Key12802624
MDR Text Key280948539
Report Number1710034-2021-00982
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number381934
Device Lot Number1082943
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2021
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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