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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEXIVA 20 GA X 1-1/4 IN SINGLE PORT; INTRAVASCULAR CATHETER
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NEXIVA 20 GA X 1-1/4 IN SINGLE PORT; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383517
Device Problems Break (1069); Leak/Splash (1354); Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that nexiva 20 ga x 1-1/4 in single port was damaged, leaked, and the packaging was deformed.This occurred on 2 occasions.The following information was provided by the initial reporter: the issue with these cannula is that the blood control line filter has become detached in at some point during manufacture, storage or transport resulting in potential blood contamination if the issue isn¿t identified before use.No patients or staff have been harmed so far, although there were some incidents of environmental blood contamination initially.All the packaging is similarly deformed.
 
Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the samples submitted for evaluation.Bd received three sealed units with all the components present.It was noted that the packaging of all three units appeared to be deformed, confirming the report of deformed packaging.Visual observation of the packages revealed there were no cracks or breaks to the bottom web (blister) , no inconsistencies to the seals, and no tears to the top web (label), all of which could compromise the sterility of the product.During manufacturing, this defect can occur during packaging forming due to incorrect parameters.There is a parameter check list and process inspection per control plan that are performed to mitigate the occurrence of this type defect.Deformed bottom webs (blister) of unit packages can also occur due to exposure to heat which causes the blister to melt and warp.If the product was exposed to heightened temperatures during transit or storage, such defect may occur.Bd was unable to determine which scenario was more likely.The units were then removed from their packaging.It was noted that the vent plugs were loose on all three devices, confirming the defect of loose vent plug.No other defects were observed.A microscopic inspection of the vent plugs was performed and no deformation or defects were observed.The vent plugs were then replaced into the luer and found to fit snug and remained in the luer on their own.During manufacturing, the vent plug is inserted into the luer adapter at a specified force but may become loose due to improper setup.There are in process tests and inspections performed per the quality control plan to mitigate the occurrence of this defect.Loosening of the vent plugs may also occur during transit and handling under abnormal conditions.Bd was unable to determine which scenario was more likely.Finally, a leak test was performed on all three units and no leakage was observed.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.
 
Event Description
It was reported that nexiva 20 ga x 1-1/4 in single port was damaged, leaked, and the packaging was deformed.This occurred on 2 occasions.The following information was provided by the initial reporter: the issue with these cannula is that the blood control line filter has become detached in at some point during manufacture, storage or transport resulting in potential blood contamination if the issue isn¿t identified before use.No patients or staff have been harmed so far, although there were some incidents of environmental blood contamination initially.All the packaging is similarly deformed.
 
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Brand Name
NEXIVA 20 GA X 1-1/4 IN SINGLE PORT
Type of Device
INTRAVASCULAR CATHETER
MDR Report Key12481888
MDR Text Key271741337
Report Number1710034-2021-00816
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903835171
UDI-Public00382903835171
Combination Product (y/n)N
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/24/2021
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 Date04/30/2024
Device Catalogue Number383517
Device Lot Number1120183
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2021
Initial Date Manufacturer Received 08/19/2021
Initial Date FDA Received09/16/2021
Supplement Dates Manufacturer Received09/24/2021
Supplement Dates FDA Received10/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2021
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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