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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD TEXIUM NEEDLE-FREE SYRINGE, 5 ML; SYRINGE, PISTON
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CAREFUSION SD TEXIUM NEEDLE-FREE SYRINGE, 5 ML; SYRINGE, PISTON Back to Search Results
Model Number MY8005
Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Patient Involvement (2645)
Event Date 01/07/2014
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
 
Event Description
It was reported by a bd associate that while searching for information on texium, a (b)(6) video was seen wherein the user was demonstrating use of needle-free syringe with bonded texium closed male luer.In the video, it was depicted that sterile water was aspirated from a vial using a needle attached to the product.The needle was then removed.A leak was observed as the user was pushing the fluid into to the needleless connector of a primary tubing while texium male luer is partially connected.There was no patient involvement.
 
Event Description
It was reported by a bd associate that while searching for information on texium, a youtube video was seen wherein the user was demonstrating use of needle-free syringe with bonded texium closed male luer.In the video, it was depicted that sterile water was aspirated from a vial using a needle attached to the product.The needle was then removed.A leak was observed as the user was pushing the fluid into to the needleless connector of a primary tubing while texium male luer is partially connected and not fully engaged into smartsite.Bd customer advocacy reached out to the youtube video content creator.The customer reported that he was informed the issue was due to improper use of the product.There was no patient involvement and no one was harmed.
 
Manufacturer Narrative
Device code added.
 
Event Description
It was reported by a bd associate that while searching for information on texium, a youtube video was seen wherein the user was demonstrating use of needle-free syringe with bonded texium closed male luer.In the video, it was depicted that sterile water was aspirated from a vial using a needle attached to the product.The needle was then removed.A leak was observed as the user was pushing the fluid into to the needleless connector of a primary tubing while texium male luer is partially connected.There was no patient involvement.
 
Manufacturer Narrative
The customer complaint of texium closed male luer leak was confirmed by evaluation of the youtube video.The video shows the user holding the syringe at an angle to the smartsite.It is likely that the texium actuator tabs are being partially engaged by the partially connected smartsite thus allowing liquid to flow through the system.The texium and smartsite present a closed system when they are fully connected per dfu and when connected properly without angling the two components when mating.Device history record could not be performed on model my8005 because the lot # for the suspect set was not provided.The root cause of this failure was not identified as no product was returned.
 
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Brand Name
TEXIUM NEEDLE-FREE SYRINGE, 5 ML
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key10138966
MDR Text Key194664225
Report Number9616066-2020-01838
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403221668
UDI-Public10885403221668
Combination Product (y/n)N
PMA/PMN Number
K071108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMY8005
Device Catalogue NumberMY8005
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PRI TUBING, THERAPY DATE (B)(6) 2014; PRI TUBING, THERAPY DATE (B)(6) 2014
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