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

Catalog Number CDC-45703-XP1A

Device Problems Device Damaged Prior to Use (2284); Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: they opened a triple lumen tray for use , and it was not a triple lumen tray inside.

Event Description

The customer reports: they opened a triple lumen tray for use , and it was not a triple lumen tray inside.

Manufacturer Narrative

(b)(4).The customer returned one, opened cvc kit for analysis.Visual analysis of the kit contents revealed that the returned catheter is a one-lumen cvc, which does not match the catheter indicated on the lidstock (multi-lumen cvc).A device history record review was performed with no relevant findings to suggest a manufacturing related cause.The report of an incorrect catheter was confirmed through examination of the received sample.A device history record review was performed with no relevant findings.Based on the customer description and the sample received, packaging caused or contributed to this event.A non-conformance request was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8975174
• MDR Text Key: 156920750
• Report Number: 1036844-2019-00940
• 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: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F18K0368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1