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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 BLOOD CONTROL TECHNOLOGY; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY; INTRAVASCULAR CATHETER Back to Search Results
Model Number 382534
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/29/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that 2 bd insyte¿ autoguard¿ bc shielded iv catheters blood control technology had a slow needle retraction.The following information was provided by the initial reporter: " it was reported resistance when pulling out of the actual iv catheter pulling the iv catheter back out of the vein.".
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that 2 bd insyte¿ autoguard¿ bc shielded iv catheters blood control technology had a slow needle retraction.The following information was provided by the initial reporter: " it was reported resistance when pulling out of the actual iv catheter pulling the iv catheter back out of the vein.".
 
Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one used un-retracted needle assembly with an opened package.Based on the reported issue of experiencing resistance with the forces between the needle and catheter tubing when removing the needle resulting in the catheter backing out of the vein, this force can be high during retraction due to insufficient lubrication on the needle and improper application including not breaking tip adhesion.Since the returned device has been used, lubrication testing cannot be performed as the original lubrication was affected by use and tests will be inaccurate.We were unable to confirm the reported issue.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.
 
Event Description
It was reported that 2 bd insyte¿ autoguard¿ bc shielded iv catheters blood control technology had a slow needle retraction.The following information was provided by the initial reporter: " it was reported resistance when pulling out of the actual iv catheter pulling the iv catheter back out of the vein.".
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
Type of Device
INTRAVASCULAR 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 Key12961982
MDR Text Key285806045
Report Number1710034-2021-01034
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903825340
UDI-Public30382903825340
Combination Product (y/n)Y
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,Followup
Report Date 12/09/2021
1 Device was Involved in the Event
1 Patient was 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 Other
Device Model Number382534
Device Catalogue Number382534
Device Lot Number1230777
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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