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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CS-12122-F
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2024
Event Type  malfunction  
Event Description
It was reported that: " on (b)(6) 2024, in icu, the doctor found the swg kinked during use on the patient.The patient was reported as fine".
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
HEMODIALYSIS SET: 2-LUMEN 12 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
elaine cully
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key19211630
MDR Text Key341357154
Report Number3006425876-2024-00406
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801902100108
UDI-Public00801902100108
Combination Product (y/n)N
Reporter Country CodeCH
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 04/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCS-12122-F
Device Lot Number71F21J1163
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2024
Date Manufacturer Received04/01/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/15/2021
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
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