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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Model Number 381834
Device Problem Retraction Problem (1536)
Patient Problems Needle Stick/Puncture (2462); Insufficient Information (4580)
Event Date 09/27/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used as a default investigation summary: our quality engineer inspected the photograph submitted for evaluation. Bd received one photo. Visual observation of the photo revealed the needle was only partially retracted and appeared to be bent. The defect of needle retraction failure was confirmed. A partial retraction may be caused by a bent needle, out of specification spring, adhesive on the outside of the hub, excessive gel, or a damaged component (i. E. , barrel). The photo did not show any damaged components. Since the unit had been used, it is unlikely that the needle was bent during manufacturing as the bend would have been noticed before use and made a venipuncture attempt unlikely; therefore, it is more likely the bend occurred after use. Although the bent needle remains a potential root cause, it could not be determined with certainty if the partial retraction occurred because of this. As a full view of the device could not be seen and no physical sample was available, no further conclusions could be drawn on whether the defect occurred in the clinician or manufacturing environment. A device history record review showed no non-conformances associated with this issue during the production of this batch. 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. We appreciate you taking the time to bring this observation to our attention. We regret any inconveniences this incident may have caused you and your facility.
 
Event Description
It was reported bd insyte¿ autoguard¿ shielded iv catheter had the needle partially retract resulting in a dirty needle stick. The following information was provided by the initial reporter: "the retraction after the safe vein retention needle is activated does not completely cause the therapist to needle".
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12692766
MDR Text Key278357377
Report Number1710034-2021-00913
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number381834
Device Catalogue Number381834
Device Lot Number1041987
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/25/2021 Patient Sequence Number: 1
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