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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER
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BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Model Number 382644
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
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 that the bd insyte¿ autoguard¿ bc shielded iv catheter experienced a needle that was partially retracted.The following information was provided by the initial reporter: i had a catheter issue reported to me regarding the needle not retracting properly.This is lot # 1064580.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2021-08-11.H6: investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one partially retracted needle assembly.During the visual examination of the unit, it was observed that the barrel was damaged (cracked), which inhibited a complete retraction and left the needle tip exposed.The reported issue was confirmed and likely related to the manufacturing process.Preventative maintenance, visual inspections, and functional testing are performed at regular intervals to mitigate the risk from this type of defect per the quality plan.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.
 
Event Description
It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter experienced a needle that was partially retracted.The following information was provided by the initial reporter: i had a catheter issue reported to me regarding the needle not retracting properly.This is lot # 1064580.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
MDR Report Key12389521
MDR Text Key268968000
Report Number1710034-2021-00768
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903826446
UDI-Public30382903826446
Combination Product (y/n)N
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/29/2024
Device Model Number382644
Device Catalogue Number382644
Device Lot Number1064580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2021
Date Manufacturer Received09/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2021
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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