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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number CS-22142-CF
Device Problem Partial Blockage (1065)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2018
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
It was reported that the doctor notices that the catheter was folded at the level "15" after insertion in the patient.Clinical consequences: issue with the "way-back" with one of the line of the catheter.Necessary to switch lines in the beginning of the dialysis.The blood flow was half what it should have been.So , the dialysis was less effective.
 
Manufacturer Narrative
(b)(4).The customer returned only the lidstock for evaluation.The actual complaint sample was not returned for investigation; therefore, visual inspection could not be performed as no sample was returned for analysis.Complaint verification testing could not be performed as no device sample was returned for analysis.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 doctor notices that the catheter was folded at the level "15" after insertion in the patient.Clinical consequences: issue with the "way-back" with one of the line of the catheter.Necessary to switch lines in the beginning of the dialysis.The blood flow was half what it should have been.So , the dialysis was less effective.
 
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Brand Name
ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ   591 01
Manufacturer Contact
linda woodall
3015 carrington mill blvd
morrisville, NC 27560
9196942566
MDR Report Key7706504
MDR Text Key114594433
Report Number3006425876-2018-00470
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/03/2019
Device Catalogue NumberCS-22142-CF
Device Lot Number71F18A0421
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/04/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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