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

Catalog Number CS-15322-VSP

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medwatch (mw5078256).It was reported on the medwatch there was a serious injury.Customer was contacted for verification.No patient injury or harm communicated to reporter.

Event Description

According to the medwatch (mw5078256) "the catheter was placed, use after placement revealed a leak at the hub.The patient required surgical intervention to repair and replace the catheter".

Manufacturer Narrative

Qn#(b)(4).Medwatch (mw5078256).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

According to the medwatch (mw5078256) "the catheter was placed, use after placement revealed a leak at the hub.The patient required surgical intervention to repair and replace the catheter".

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 27 CM
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7784414
• MDR Text Key: 117141856
• Report Number: 1036844-2018-00228
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CS-15322-VSP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/15/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention