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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4 FR X 5 CM; CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4 FR X 5 CM; CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CS-12402
Device Problem Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/02/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
The complaint is reported as: they report from the neonatal icu that the surgeon tries to pass a right subclavian central venous catheter arrow 4 fr x 5 cm, on the first attempt she obtains good return from both lines, but the proximal line of the catheter is hard at the time of salinization, therefore the catheter is removed, it becomes permeabilized and is obstructed in said pathway.A change of the catheter is required and the procedure is tried again, which is achieved on the fourth attempt in the left subclavian.It was reported institutional protocol standards are met for passage of the central venous catheter, the catheter is purged, passed and a return is obtained, but it does not allow to infuse fluids, when withdrawing it is obstructed.No patient harm was reported.
 
Event Description
The complaint is reported as: they report from the neonatal icu that the surgeon tries to pass a right subclavian central venous catheter arrow 4 fr x 5 cm, on the first attempt she obtains good return from both lines, but the proximal line of the catheter is hard at the time of salinization, therefore the catheter is removed, it becomes permeabilized and is obstructed in said pathway.A change of the catheter is required and the procedure is tried again, which is achieved on the fourth attempt in the left subclavian.It was reported institutional protocol standards are met for passage of the central venous catheter, the catheter is purged, passed and a return is obtained, but it does not allow to infuse fluids, when withdrawing it is obstructed.No patient harm was reported.
 
Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided four photos for analysis.The complaint of an extension line blocked was not able to be confirmed by the photos.Biological material was noted on the catheter body, but a blockage was not observed.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit instructs the user, "flush lumen(s) to completely clear blood from catheter." the customer report of a blocked extension line was not able to be confirmed by visual inspection of the customer supplied photos.Full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW CVC SET: 2-LUMEN 4 FR X 5 CM
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key12212261
MDR Text Key263569219
Report Number9680794-2021-00360
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/05/2021
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 Health Professional
Device Catalogue NumberCS-12402
Device Lot Number14F20J0125
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/05/2021
Initial Date FDA Received07/22/2021
Supplement Dates Manufacturer Received08/04/2021
Supplement Dates FDA Received08/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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