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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 22G X 1.00 IN GLOBAL; INTRAVASCULAR CATHETER
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA DIFFUSICS 22G X 1.00 IN GLOBAL; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383692
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2019
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone #: unknown.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 a ct patient was successfully inserted with a bd nexiva diffusics 22g x 1.00 in global, when the luer was connected to the pump injector and patient was injected with saline, the pressure on injector reached 200+ psi and saline entered patients tissue.The following information was provided by the initial reporter: care and maintenance training being conducted in all clinical areas as part of the implementation of bd nexiva diffusics in the ct department by bd representatives.On visiting the ct department i asked the radiographers if they had any issues as the department has been using the cannula for the past number of months.An issue was reported where when conducting ct scans with power injection using a 22g bd nexiva diffusics at 5ml/sec flow rate where the power injector pressure limited and stopped the infusion of contrast.I asked that if there were any patients today who were to receive contrast infusion at this flow rate for them to contact me so that i could observe.Ct called to inform me that there was a patient for ct angio at 9.45 and i attended same.The cannula was first time inserted without trouble and flushed using posiflush sp as normal.The luer connection was connected to the pump injector directly using the standard tubing used by the department and the tubing was primed prior to this with saline.On commencement of the scan 30mls of saline was initially injected by the pump injector and the pressure reached 200+ psi and the radiographer, recognizing that this was not normal, stopped the injection.The saline had gone into the tissue.No contrast fluid was injected at this stage.It was commented by staff in the unit that with a 'normal' cannula that the injector would have pressure limited with a much lower volume injected into the tissue than the bd nexiva diffusics.It was also observed that the bd nexiva diffusics, despite being tested to 6.5ml/sec using omnipaque 350, was pressure limiting at 5.0ml/sec at 325psi using the same contrast media.It was also observed that patients had to have their arms extremely straight to try and combat this issue.
 
Manufacturer Narrative
H.6.Investigation: a device history review was conducted for lot number 8276932.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally the returned samples were subjected to occlusion testing; the results found the flow of fluid through the device to be unobstructed and closer review of the devices was unable to identify the presence of any observable non-conformance.Unfortunately without the ability to observe the reported failure mode, the root cause for this complaint could not be determined at the conclusion of our review.
 
Event Description
It was reported that a ct patient was successfully inserted with a bd nexiva diffusics 22g x 1.00 in global, when the luer was connected to the pump injector and patient was injected with saline, the pressure on injector reached 200+ psi and saline entered patients tissue.The following information was provided by the initial reporter: care and maintenance training being conducted in all clinical areas as part of the implementation of bd nexiva diffusics in the ct department by bd representatives.On visiting the ct department i asked the radiographers if they had any issues as the department has been using the cannula for the past number of months.An issue was reported where when conducting ct scans with power injection using a 22g bd nexiva diffusics at 5ml/sec flow rate where the power injector pressure limited and stopped the infusion of contrast.I asked that if there were any patients today who were to receive contrast infusion at this flow rate for them to contact me so that i could observe.Ct called to inform me that there was a patient for ct angio at 9.45 and i attended same.The cannula was first time inserted without trouble and flushed using posiflush sp as normal.The luer connection was connected to the pump injector directly using the standard tubing used by the department and the tubing was primed prior to this with saline.On commencement of the scan 30mls of saline was initially injected by the pump injector and the pressure reached 200+ psi and the radiographer, recognizing that this was not normal, stopped the injection.The saline had gone into the tissue.No contrast fluid was injected at this stage.It was commented by staff in the unit that with a 'normal' cannula that the injector would have pressure limited with a much lower volume injected into the tissue than the bd nexiva diffusics.It was also observed that the bd nexiva diffusics, despite being tested to 6.5ml/sec using omnipaque 350, was pressure limiting at 5.0ml/sec at 325psi using the same contrast media.It was also observed that patients had to have their arms extremely straight to try and combat this issue.
 
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Brand Name
BD NEXIVA DIFFUSICS 22G X 1.00 IN GLOBAL
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX 
MDR Report Key8804406
MDR Text Key151506411
Report Number9610847-2019-00472
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K173354
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 09/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2021
Device Catalogue Number383692
Device Lot Number8276932
Date Manufacturer Received07/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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