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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 20 GA 1.00 IN; INTERVASCULAR CATHETER
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 20 GA 1.00 IN; INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383693
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2021
Event Type  malfunction  
Event Description
It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system 20 ga 1.00 in experienced a safety mechanism that would not disengage.The following information was provided by the initial reporter: when the mandrel/needle was to be detached from pivc/nexiva, it did not work.It got stuck in a extendable position.
 
Manufacturer Narrative
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¿ diffusics¿ closed iv catheter system 20 ga 1.00 in experienced a safety mechanism that would not disengage.The following information was provided by the initial reporter: when the mandrel/needle was to be detached from pivc/nexiva, it did not work.It got stuck in a extendable position.
 
Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the 3 photos submitted for evaluation.The reported issue was confirmed upon inspection of the photos.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.
 
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Brand Name
BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 20 GA 1.00 IN
Type of Device
INTERVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX 
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX  
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12961943
MDR Text Key285673709
Report Number9610847-2021-00585
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K173354
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2024
Device Catalogue Number383693
Device Lot Number1179394
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/09/2021
Initial Date FDA Received12/08/2021
Supplement Dates Manufacturer Received12/13/2021
Supplement Dates FDA Received01/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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