MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 15 FR X 31 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15362-VSP

Device Problems Leak/Splash (1354); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: for a dialysis (b)(6) female patient), before connecting the catheter, a leak was observed at the level of the connector of the catheter.The catheter was inserted since (b)(6) 2018.A folding was observed while using a x ray after insertion.We had noticed that the catheter was not working properly since its insertion.

Manufacturer Narrative

(b)(4).The customer returned a 2-lumen hemodialysis connector piece connected to a catheter body for investigation.No defects or anomalies were found during visual inspection of the catheter and connector piece.The connector/catheter assembly was leak tested by injecting water into each extension line using the lab leak tester.Each lumen was pressurized with water to 45psi for 30 seconds.The distal end of the catheter was occluded during testing to restrict flow.No leaks were observed in any area of the assembly.A device history record review was performed and no relevant findings were identified.The instructions-for-use included in the kit describes suggested techniques to minimize the likelihood of catheter damage or leakage (air or fluid) during use.The reported complaint of catheter body leakage could not be confirmed by complaint investigation.The returned connector piece and catheter passed visual inspection and no leaks were found during functional inspection of the devices.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.No problem was found with the returned sample.

Event Description

The customer reports: for a dialysis ((b)(6) female patient), before connecting the catheter, a leak was observed at the level of the connector of the catheter.The catheter was inserted since (b)(6) 0218.A folding was observed while using a x ray after insertion.We had noticed that the catheter was not working properly since its insertion.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 31 CM
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7601039
• MDR Text Key: 111053806
• Report Number: 1036844-2018-00169
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• PMA/PMN Number: K111117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: CS-15362-VSP
• Device Lot Number: 23F17G0644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Date Manufacturer Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR