MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 4-L 8.5 FR X 20 CM AGB; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CDC-45854-XP1A

Device Problem Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the tissue dilator was different.The quality of the dilator was subpar and did not provide adequate force for cannulation.The issue was detected when used on a patient that was crashing and unstable.No negative impact to the patient was reported.

Event Description

The customer reports that the tissue dilator was different.The quality of the dilator was subpar and did not provide adequate force for cannulation.The issue was detected when used on a patient that was crashing and unstable.No negative impact to the patient was reported.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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.

• Brand Name: ARROW PI CVC KIT: 4-L 8.5 FR X 20 CM AGB
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9156750
• MDR Text Key: 174898754
• Report Number: 1036844-2019-00964
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

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: Health Professional
• Device Catalogue Number: CDC-45854-XP1A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1