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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

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BECTON DICKINSON UNSPECIFIED BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/29/2020
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that catheter and hub separated while inserted and broke off in patients vein with a unspecified bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter: (1 of 2 complaints) it was reported the catheter and hub became separated while inserted in patient.Additional information received from customer: power injector reached max pressure on injection but enhancement was adequate for image acquisition.Post scan iv catheter noted to have broken off in patient's vein.Ed provider and rn called to ct.Ed physician removed catheter with no known complication.
 
Manufacturer Narrative
H.6.Investigation summary : bd received one photograph which displayed the catheter appearing separated from the rest of the unit.The reported issue was confirmed.This type of failure is likely to be a manufacturing process related issue.The failure mode of ¿catheter wedge back out¿ could potentially be caused by incorrect swage depth or incorrect flare length.Measurements could not be performed without the actual sample; and the photo did not provide sufficient details to identify any molding defects that may potentially affect the swaging process.A device history review could not be completed as no batch number was provided.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 section h.10.
 
Event Description
It was reported that catheter and hub separated while inserted and broke off in patients vein with a unspecified bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter: (1 of 2 complaints) it was reported the catheter and hub became separated while inserted in patient.Additional information received from customer: power injector reached max pressure on injection but enhancement was adequate for image acquisition.Post scan iv catheter noted to have broken off in patient's vein.Ed provider and rn called to ct.Ed physician removed catheter with no known complication.
 
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Brand Name
UNSPECIFIED BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key9733353
MDR Text Key188336631
Report Number2243072-2020-00250
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 04/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 01/31/2020
Initial Date FDA Received02/20/2020
Supplement Dates Manufacturer Received01/31/2020
Supplement Dates FDA Received04/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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