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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 23 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

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ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR; CATHETER, HEMODIALYSIS, IMPLA Back to Search Results
Catalog Number CS-15232-VFE
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: the user was unable to aspirate blood from the blue lumen during use on patient.They then removed the hub assembly and injected saline into the lumen but noted a leak between the assembly and the metal.The catheter was replaced to complete the procedure and there was no reported patient harm or consequence.
 
Manufacturer Narrative
Qn# (b)(4).The customer report of a catheter leak was confirmed through complaint investigation of the returned sample.The customer returned one hemodialysis catheter connector for analysis.The threaded compression sleeve, the catheter body, and the compression sleeve were not returned for analysis.After failing functional testing, a leak was observed where the metal prongs meet the juncture hub of the connector assembly.A leak test was performed on the connector assembly.With the distal ends of the metal prongs occluded, water was injected using a lab inventory 10ml syringe through each of the extension lines.When injecting water through the lumen with the red clamp, a leak was observed at the connection point between the metal prongs and the juncture hub.No leaks were observed when injecting water through the lumen with the blue extension line.The instructions-for-use (ifu) provided with the kit informs the user "ensure compression sleeve is securely positioned inside threaded compression cap.Avoid attempts to place compression sleeve onto hub connection assembly cannula and then apply threaded compression cap.Incomplete compression may occur causing catheter separation." a device history record review was performed with no relevant findings.Based on the condition of the returned device and the customer description, manufacturing caused or contributed to this event.Investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
It was reported that: the user was unable to aspirate blood from the blue lumen during use on patient.They then removed the hub assembly and injected saline into the lumen but noted a leak between the assembly and the metal.The catheter was replaced to complete the procedure and there was no reported patient harm or consequence.
 
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Brand Name
ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 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
kevin don bosco
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17225102
MDR Text Key318126163
Report Number9680794-2023-00470
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeJA
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 06/02/2023
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 NumberCS-15232-VFE
Device Lot Number13F22H0666
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/02/2023
Initial Date FDA Received06/29/2023
Supplement Dates Manufacturer Received07/19/2023
Supplement Dates FDA Received07/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2022
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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