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 07/30/2017

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 no issues were identified, other than a non-arrow clamp being place on the arterial extension line rather than the clamp that is supplied.The clamp was broken on the sides, indicating it had been placed on the line by the end user.A lab syringe was used to pass water through both extension lines.No issues were identified.A device history record 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 arterial extension line being separated was not confirmed during sample investigation.Both extension lines were found to be intact during visual and functional inspections.A non-arrow clamp was found on the arterial extension line that appeared to have been placed on by the end user.No problem was identified with the returned sample.

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: 6800113
• MDR Text Key: 82916485
• Report Number: 1036844-2017-00313
• 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: company representative,foreig
• 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: 08/17/2017
• 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
• Patient Age: 62 YR