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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INSYTE AUTOGUARD BC 20GA X 1.16 IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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BD INSYTE AUTOGUARD BC 20GA X 1.16 IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number REF 382534
Device Problems Break (1069); Entrapment of Device (1212); Fluid Leak (1250)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/16/2021
Event Type  Injury  
Event Description
Inpatient on medical/surgical floor had an iv in place, reported the site was leaking. Upon removal by the rn the catheter was separate from the iv hub. Md informed and came to assess patient. Silicone catheter still in patients ac iv site (within the vein), confirmed by ultrasound. Required transport to higher level of care for surgical removal. Findings consistent with a 3. 1 cm retained catheter fragment associated with thrombus around its distal tip just proximal to the left antecubital fossa within the distal left basilic vein. Surgical consultation is recommended. Fda safety report id # (b)(4).
 
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Brand NameBD INSYTE AUTOGUARD BC 20GA X 1.16 IN
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12324868
MDR Text Key266901697
Report NumberMW5103248
Device Sequence Number1
Product Code FOZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberREF 382534
Device Lot Number0322327
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/13/2021 Patient Sequence Number: 1
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