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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 10/25/2021
Event Type  malfunction  
Event Description
It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter needle failed to retract when the button was pressed.The following information was provided by the initial reporter, translated from (b)(6) to english: "this is a report about needle retraction failure of iagbc.According to the customer¿s report, the hcp pressed the button to activate the safety mechanism but the needle was not retracted.".
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
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 that the bd insyte¿ autoguard¿ bc shielded iv catheter needle failed to retract when the button was pressed.The following information was provided by the initial reporter, translated from (b)(6) to english: "this is a report about needle retraction failure of iagbc.According to the customer¿s report, the hcp pressed the button to activate the safety mechanism but the needle was not retracted.".
 
Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one used unit and seven photos.Upon inspection of the received unit and the photos, it was identified that adhesive was present on the exterior of the needle hub.Retraction was attempted by pressing the button but retraction did not occur.The reported defect was confirmed.Upon applying excess force, a crackling sound was heard and the unit retracted.Inspection of the separated components found that adhesive was also present between the button and needle hub which likely prevented retraction from initially occurring.During manufacturing, adhesive may be incorrectly placed due to adhesive build up or part misalignment.Preventative maintenance and in process sampling are performed at regular intervals 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 that the bd insyte¿ autoguard¿ bc shielded iv catheter needle failed to retract when the button was pressed.The following information was provided by the initial reporter, translated from japanese to english: "this is a report about needle retraction failure of iagbc.According to the customer¿s report, the hcp pressed the button to activate the safety mechanism but the needle was not retracted.".
 
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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 Key12858158
MDR Text Key285774064
Report Number1710034-2021-01010
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 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2023
Device Catalogue Number381023
Device Lot Number1025765
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2021
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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