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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CV-12703
Device Problem Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2023
Event Type  malfunction  
Event Description
It was reported that the catheter has an "obstructed flow on the distal part of the cvc, they have difficulties on flushing and guidewire insertion".The device was removed in its entirety.No patient harm was reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the catheter has an "obstructed flow on the distal part of the cvc, they have difficulties on flushing and guidewire insertion".The device was removed in its entirety.No patient harm was reported.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations.Check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed.Warning: open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, 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: 3-LUMEN 7 FR X 16 CM
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ   591 01
Manufacturer Contact
kevin don bosco
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17073177
MDR Text Key317068776
Report Number3006425876-2023-00539
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/11/2023
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 Catalogue NumberCV-12703
Device Lot Number71F22A2555
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/11/2023
Initial Date FDA Received06/06/2023
Supplement Dates Manufacturer Received06/26/2023
Supplement Dates FDA Received06/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NOT REPORTED; NOT REPORTED
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