MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15272-VFE

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "when they wanted to perform dialysis the machine first sucked air and when they tried to switched lumens blood leaked from the compression hub.The dialysis center was unable to perform dialysis on the patient.".

Manufacturer Narrative

Qn# (b)(4).The customer returned one connector assembly with "arrow vectorflow" printed on the juncture hub.The catheter was not returned by the customer.The connector assembly showed evidence of use.The customer returned a photo of the catheter in the patient.In the photo, the catheter appears to be leaking blood near the juncture hub; however, the exact location of the leak is unclear.Visual inspection with and without magnification did not reveal and defects or anomalies.Because the catheter in question was not returned with the assembly, a lab catheter was used for testing according to chronic hemodialysis catheter module requirements which is based on bs en iso 10555-1, 4.7.1.The venous and arterial extension lines were pressurized with water to 45psi for 30 seconds with the venous and arterial tips occluded.No leaks were observed from either extension lines.A device history record review was performed on the catheter and no relevant findings were found to suggest a manufacturing issue.The product ifu describes the technique for seating the hub connection assembly into the catheter body.The ifu cautions 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." the ifu also notes, "green compression sleeve must be present when threading compression cap onto hub connection assembly.Failure to do so may result in air embolism, blood loss, or catheter separation." complaint verification testing could not be performed as the catheter was not returned for analysis.While performing a leak test on the returned connector assembly and lab catheter, no leaking was observed.Based on the testing performed and the returned components, probable cause of the leaking cannot be determined as the catheter was not returned for the investigation.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that "when they wanted to perform dialysis the machine first sucked air and when they tried to switched lumens blood leaked from the compression hub.The dialysis center was unable to perform dialysis on the patient.".

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7872703
• MDR Text Key: 120137293
• Report Number: 1036844-2018-00243
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K141051
• Number of Events Reported: 1
• 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: 08/31/2018

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 Operator: Health Professional
• Device Catalogue Number: CS-15272-VFE
• Device Lot Number: 23F17G075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 10/18/2018
• Supplement Dates FDA Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 64