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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR; CATHETER, HEMODIALYSIS, IMPLA
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ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR; CATHETER, HEMODIALYSIS, IMPLA Back to Search Results
Catalog Number CS-15272-VFE
Device Problem Separation Failure (2547)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2022
Event Type  malfunction  
Event Description
It was reported that: during the removal of the peel away sheath, the user had difficulty to properly peel away the sheath.The sheath did not tear properly.The user had to use a scalpel to cut the sheath, with no consequence for the patient, just a slightly prolonged procedure.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: during the removal of the peel away sheath, the user had difficulty to properly peel away the sheath.The sheath did not tear properly.The user had to use a scalpel to cut the sheath, with no consequence for the patient, just a slightly prolonged procedure.
 
Manufacturer Narrative
Qn#(b)(4).The customer returned one safe-sheath for evaluation.The dilator was not returned.Visual inspection of the sheath confirmed that it had not torn down its score lines.The sheath was wavy and deformed at the locations of separation.A portion of the sheath fully separated from the main sheath body.Per the dilator sheath product drawing, the total length of dilator should measure 8.50" with the hub assembly measuring 2.15".This means that the length of the component from the tip of the dilator to the sheath hub should be 6.35".The length of dilator tip that extends past the sheath should measure 1.34" +/- 0.30"; therefore, the length of the sheath body should measure between 4.71-5.31".The length of the sheath body measured 5.125" , which is within the specifications per product drawing.Functional testing could not be performed due to the damage to the returned sheath.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit states "introduce catheter through hemostasis valve/sheath and advance to desired position.Sharply snap the tabs of valve housing in a plane perpendicular to the long axis of sheath to split valve and split sheath apart while withdrawing from vessel." the customer report of a sheath tearing incorrectly was confirmed by a complaint investigation of the returned sample.The returned sheath did not separate along the score lines as intended.A device history record review was performed, and no relevant findings were identified.Based on the sample returned and the fact that the sheath is a purchased component, this is likely a supplier issue.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on complaints of this nature.
 
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Brand Name
ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR
Type of Device
CATHETER, HEMODIALYSIS, IMPLA
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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key15849116
MDR Text Key305607280
Report Number9680794-2022-00739
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K141051
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 11/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCS-15272-VFE
Device Lot Number13F22C0874
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received12/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2022
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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