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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
Catalog Number 381023
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter, the device experienced needle would not retract.The following information was provided by the initial reporter.The customer stated: the customer's report is that the safety mechanism didn't work.
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter, the device experienced needle would not retract.The following information was provided by the initial reporter.The customer stated: the customer's report is that the safety mechanism didn't work.
 
Manufacturer Narrative
Investigation: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one used 22g x 1.00in.Insyte autoguard bc pro unit from lot number 1104380.Additionally, six photographs were provided for investigation which displayed the last coil on the distal end of the spring appearing to be out of place.A gross visual inspection of the returned sample found that the button was pressed down, but the needle was not retracted.Further microscopic inspection did not find any adhesive or bound spring coils.As the out of place coil seen on the images was not observed with the unit un-retracted, the unit was forcibly retracted.Upon retraction of the unit, the distal end of the spring could be seen reaching into the needle hub area.The defect was attempted to be replicated using the returned unit.Upon pushing the needle back out, the last coil of the spring got jammed between the needle hub and body of the grip, preventing the needle from retracting.The spring was further inspected, and no damage was found to the surface of the spring itself.However, the last coil was found to be smaller in diameter then the other coils.A damaged spring may potentially alter the springs dimensions, causing it to sit incorrectly against the ridge on the inside of the grip, which prevents it from popping out.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to incorrect equipment settings or machine misalignment.Functional testing is performed for needle retraction per the sampling and quality control plan to mitigate the risk from this type of defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
Event Description
It was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter, the device experienced needle would not retract.The following information was provided by the initial reporter.The customer stated: the customer's report is that the safety mechanism didn't work.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
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 Key12923746
MDR Text Key285805849
Report Number1710034-2021-01029
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2024
Device Catalogue Number381023
Device Lot Number1104380
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2021
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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