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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD INSYTE AUTOGUARD BC 20GA X 1.16 IN; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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BD 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/Blood 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 Name
BD INSYTE AUTOGUARD BC 20GA X 1.16 IN
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BD
MDR Report Key12324868
MDR Text Key266901697
Report NumberMW5103248
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903825349
UDI-Public(01)00382903825349
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2023
Device Catalogue NumberREF 382534
Device Lot Number0322327
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/13/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age22 YR
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