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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM) INTERVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM) INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383536
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 10/01/2019
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 that the bd nexiva dual port 20ga 1. 00in (1. 1 mm x 25 mm) experienced defective/damaged tubing and leakage during use. The following information was provided by the initial reporter: cannulated patient and noticed that there was a small hole in the tubing of the cannula which was causing blood to leak from the tube. The hole was located just below the clamp. Cannula is a bd 20 gauge lot 9169950, expiry:2022-05-31, ref 383536. Action taken: cannula discarded as contaminated with patient blood. Aware and will check all batches.
 
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Brand NameBD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM)
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9194327
MDR Text Key172705243
Report Number1710034-2019-01114
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383536
Device Lot Number9169950
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/15/2019 Patient Sequence Number: 1
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