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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD INSYTE-N AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BECTON, DICKINSON AND COMPANY BD INSYTE-N AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 381511
Device Problems Material Fragmentation (1261); Difficult to Insert (1316); Activation, Positioning or SeparationProblem (2906); Material Integrity Problem (2978); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 01/06/2021
Event Type  malfunction  
Event Description
Multiple complaints from nursing staff of bd intravascular catheters splintering or splitting. Upon single attempt, the plastic sheath of cahtheter splinters when needle is re-introduced. On initial insertion, there have been complaints of needle not cannulating the skin/vein easily and resistance is met. Iv infiltrates appear to be trending up. Below is some of the descriptions that have been shared: the catheter is hard to cannulate the skin "almost as the skin is tough and i know it is not". "i meet resistance if i need to reintroduce the needle into the catheter". "it doesn't seem to thread right". "it doesn't feel right when i puncture the skin". "when i pull it out the catheter is splintered or torn" (after iv attempt was unsuccessful).
 
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Brand NameBD INSYTE-N AUTOGUARD
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417
MDR Report Key11494550
MDR Text Key240081357
Report Number11494550
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381511
Device Catalogue Number381511
Device Lot Number0195143 0080379 0119474 026501
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/10/2021
Event Location Hospital
Date Report to Manufacturer03/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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