MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER HEMODIALYSIS IMPLANTE

Catalog Number CDC-45703-XP1A

Device Problems Device Damaged Prior to Use (2284); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer said the guidewire did not advance easily, it kinked, and led to a delay in care to the patient since they had to open an additional kit.The alleged issue was detected prior to patient use.

Manufacturer Narrative

Qn# (b)(4).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

Customer said the guidewire did not advance easily, it kinked, and led to a delay in care to the patient since they had to open an additional kit.The alleged issue was detected prior to patient use.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: CATHETER HEMODIALYSIS IMPLANTE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8882967
• MDR Text Key: 153983527
• Report Number: 1036844-2019-00888
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F19C0321
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1