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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL LLC CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CV-17702-E
Device Problems Fluid/Blood Leak (1250); Material Perforation (2205)
Patient Problem Insufficient Information (4580)
Event Date 02/20/2024
Event Type  malfunction  
Event Description
It was reported that: "the catheter was inserted into the patient in the scd region, and the dressing was soaked, requiring several changes during shifts.The catheter was removed and verified that it was perforated.".
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
 
Event Description
It was reported that: "the catheter was inserted into the patient in the scd region, and the dressing was soaked, requiring several changes during shifts.The catheter was removed and verified that it was perforated.".
 
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Brand Name
CVC SET: 2-LUMEN 7 FR X 20 CM
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX   31200
Manufacturer Contact
elaine cully
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18904475
MDR Text Key337691340
Report Number9680794-2024-00219
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801902105455
UDI-Public00801902105455
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
Reporter Occupation Other
Type of Report Initial
Report Date 02/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCV-17702-E
Device Lot Number14F22C0275
Was Device Available for Evaluation? No
Date Manufacturer Received02/20/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/07/2022
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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