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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR
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CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number ME2017
Device Problems Fitting Problem (2183); Failure to Disconnect (2541)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
It was reported that the tip of the syringe tip broke off inside the female luer of the extension tubing set.Although requested, further information was not provided.
 
Event Description
There was an unexpected return of a tubing set where a photo taken when the product arrived appeared to show the syringe tip broken off inside the female luer of the extension tubing set.Although requested, further information was not provided.
 
Event Description
There was an unexpected return of a tubing set where a photo taken when the product arrived appeared to show the syringe tip broken off inside the female luer of the extension tubing set.Although requested, further information was not provided.
 
Manufacturer Narrative
Section a: per previous discussion with the customers at (b)(6) hospitals, they are unable to give any patient information.This was an unexpected return.Visual inspection observed the syringe's broken off tip was lodged within the set's female luer.No further issue was observed with the set.The set was inspected for kinks, holes/tears in the tubing, or damages to the components.Further visual inspection of the syringe (barrel flange mold number n-36 and cavity 12) observed no other issue.The broken off syringe tip was unable to be removed.No testing was able to be performed.The device history record for model me2017 could not be performed due to no lot number being provided for the reported suspect set sample.
 
Event Description
There was an unexpected return of a tubing set where a photo taken when the product arrived appeared to show the syringe tip broken off inside the female luer of the extension tubing set.Although requested, further information was not provided.
 
Manufacturer Narrative
Correction on follow-up(1): g.4 (03/04/2020).
 
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Brand Name
ALARIS EXTENSION SET
Type of Device
SET, EXTENSION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9925585
MDR Text Key194123739
Report Number9616066-2020-01261
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403236242
UDI-Public10885403236242
Combination Product (y/n)N
PMA/PMN Number
K051499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup,Followup
Report Date 03/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberME2017
Device Catalogue NumberME2017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PRI TUBING,10ML BD1 SYRINGETHERAPY DATE UNK.
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