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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 382534
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2021
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 missing label or no label information.The following information was provided by the initial reporter.The customer stated: it was reported missing label description on the outer package we have 7 bd insystes with no marking on them.
 
Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the devices submitted for evaluation.Bd received eight sealed packages, seven of which were lacking printed product information.The issue was confirmed.Preventative maintenance logs were reviewed, which verified all printing equipment and vision detection systems were up to date and functioning properly.The missing print most likely occurred as a result of human error during the manual inspection process.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.H3 other text : see h10.
 
Event Description
It was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter, the device experienced missing label or no label information.The following information was provided by the initial reporter.The customer stated: it was reported missing label description on the outer package we have 7 bd insystes with no marking on them.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
MDR Report Key12442047
MDR Text Key271331436
Report Number1710034-2021-00786
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903825340
UDI-Public30382903825340
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 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/29/2024
Device Model Number382534
Device Catalogue Number382534
Device Lot Number1076477
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2021
Date Manufacturer Received09/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/17/2021
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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