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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 18 G X 1.25 IN. (1.3 MM X 31 MM) BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 18 G X 1.25 IN. (1.3 MM X 31 MM) BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383539
Device Problems Detachment Of Device Component (1104); Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/18/2017
Event Type  malfunction  
Manufacturer Narrative
Original mdr had incorrect "date received by manufacturer". Correct date is 09/18/2017.
 
Manufacturer Narrative
New information shows that the original mdr did have the correct "date received by manufacturer". Correct aware date is 08/18/2017.
 
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. Results: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. A device history review was not conducted because a lot number could not be determined. Conclusion: bd was unable to confirm the customer¿s indicated failure mode because no samples or photos were received to confirm the stated defect. (b)(4).
 
Event Description
It was reported that the needle was separating from the 18 g x 1. 25 in. (1. 3 mm x 31 mm) bd nexiva¿ closed iv catheter system, then blood leaked during use. No reported medical intervention or serious injury.
 
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Brand Name18 G X 1.25 IN. (1.3 MM X 31 MM) BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVASCULAR 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
8015652845
MDR Report Key6883152
MDR Text Key256281428
Report Number1710034-2017-00240
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K111366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383539
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/21/2017 Patient Sequence Number: 1
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