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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number CV-15703-E
Device Problem Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2023
Event Type  malfunction  
Event Description
It was reported that: "after insertion, one of the lumens wasn't functioning.It wasn't aspirating.Other lumens were working accordingly" the issue was identified during use on patient.No reported patient harm.Reported as fine.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: "after insertion, one of the lumens wasn't functioning.It wasn't aspirating.Other lumens were working accordingly" the issue was identified during use on patient.No reported patient harm.Reported as fine.
 
Manufacturer Narrative
(b)(4).The customer report of a blocked extension line was not able to be confirmed by visual inspection of the customer supplied photos and a full complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with the kit informs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".The ifu also states, "flush lumen(s) to completely clear blood from catheter".A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, 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 7FR X 20CM
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 Key17163353
MDR Text Key317502076
Report Number3006425876-2023-00585
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/23/2023
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-15703-E
Device Lot Number71F20D0640
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/23/2023
Initial Date FDA Received06/20/2023
Supplement Dates Manufacturer Received07/11/2023
Supplement Dates FDA Received07/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/09/2020
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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