MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15242-VSP

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that after three months of insertion, for hemodialysis in the hospital, the doctor found the red tube broken and air was in the tube.The device was removed and replaced without issue.

Manufacturer Narrative

(b)(4).Customer returned one used j-71524-001 connector assembly for evaluation.Visual inspection was performed and the arterial extension line hub was confirmed to be separated from the connector assembly.The fracture surfaces were examined and determined to have the characteristics of those caused by contact with a sharp object.A device history record (dhr) review was performed and no relevant findings were identified.The instructions-for-use (ifu) that are packaged with this product caution against altering the catheter during insertion , use, or removal (except as instructed).The customer reported issue of the separated extension line was confirmed during the sample investigation.During the visual inspection the arterial extension line hub was found to be separated from the extension line.The fracture surfaces were examined and determined to have been caused by contact with a sharp object.Based on the information provided and the condition of the sample returned the probable cause of this issue is operational context.

Event Description

The customer reports that after three months of insertion, for hemodialysis in the hospital, the doctor found the red tube broken and air was in the tube.The device was removed and replaced without issue.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 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: 6798616
• MDR Text Key: 82939739
• Report Number: 1036844-2017-00312
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: CS-15242-VSP
• Device Lot Number: 23F14J0180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2014
• 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