MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 15 FR X 50 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15552-VSP

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if the device sample is available for evaluation.

Event Description

The customer reports: the patient returned to the hospital for a review and the hub of the dialysis catheter was found to be leaking.A crack was identified by the doctor.The hub was replaced.

Manufacturer Narrative

(b)(4).The customer returned the connector assembly from a chronic hemodialysis catheter for evaluation.The connector was returned with caps on both extension lines and showed evidence of use.Visual examination revealed that both the luer hubs on both the venous and arterial extension lines were cracked/damaged.The luer hubs had significant white scuff/stress marks and the luer thread portions were cracked in multiple locations.The damage appeared consistent with connectors being aggressively tightened on the luer hubs.The luer hubs were compared to undamaged lab inventory luer hubs and no molding differences were observed.Evidence of use was observed on the outside and inside of both of the extension lines.With the distal end of the connector occluded water was injected into each extension line using a lab inventory 10ml syringe.Water was observed to be leaking from each of the luer hubs when pressurized with water.The instructions-for-use (ifu) supplied with this kit cautions the user that "repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure." the ifu also notes "do not use acetone with this catheter or catheter degradation may occur." the customer report that the catheter leaked from the extension line luer hubs was confirmed through evaluation of the returned sample.Both the arterial and venous extension line luer hubs were cracked and leaked during functional leak testing.The damage to the luer hubs was consistent with connectors being aggressively tightened on the luer hubs.Based on the condition of the returned device and the report that the damage was observed during use, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: the patient returned to the hospital for a review and the hub of the dialysis catheter was found to be leaking.A crack was identified by the doctor.The hub was replaced.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 50 CM
• 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: 7421393
• MDR Text Key: 105422590
• Report Number: 1036844-2018-00115
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K111117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-15552-VSP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2018
• 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