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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 CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC CATHETER INTRAVASCULAR CATHETER Back to Search Results
Model Number 382637
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/05/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: our quality engineer inspected the photograph submitted for evaluation. The photo displayed the labels of two packages from material #382637, lot #0190042. Visual observation of the photo revealed there was no view of a device for investigation. Unfortunately, the photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause. Additional inspections or investigation into the reported defect could not be performed without the physical sample. A device history record review showed no non-conformance's associated with this issue during the production of this batch. Quality records have been consulted for tracking and trending purposes and this was the first occurrence of this failure mode. 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 while using a bd insyte¿ autoguard¿ bc catheter the needle would not retract. There was no report of patient or user impact.   the following information was provided by the initial reporter: it was reported by the medical professional, needle did not retract into the housing.
 
Manufacturer Narrative
Investigation summary: our quality engineer inspected the photograph submitted for evaluation. The photo displayed the labels of two packages from material #382637, lot #0190042. Visual observation of the photo revealed there was no view of a device for investigation. Unfortunately, the photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause. Additional inspections or investigation into the reported defect could not be performed without the physical sample. A device history record review showed no non-conformance's associated with this issue during the production of this batch. Quality records have been consulted for tracking and trending purposes and this was the first occurrence of this failure mode. 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 while using a bd insyte¿ autoguard¿ bc catheter the needle would not retract. There was no report of patient or user impact.   the following information was provided by the initial reporter: it was reported by the medical professional, needle did not retract into the housing.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ BC 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12965108
MDR Text Key285806414
Report Number1710034-2021-01038
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 11/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number382637
Device Catalogue Number382637
Device Lot Number0190042
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/08/2020
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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