MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 2-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CA-22702

Device Problems Crack (1135); Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports a cracked tray.

Manufacturer Narrative

Qn#(b)(4).The customer did not return the sample; however one photo was provided of the defective sample.Visual inspection of the photo confirmed that the outer tray had cracked.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.The complaint of a cracked tray was confirmed by the photo the customer sent.A device history record review was performed and no relevant findings were identified.The probable cause of this defect is design related.A non-conformance has been created to further investigate this cracked tray, sterility issue.

Event Description

The customer reports a cracked tray.

• Brand Name: ARROW CVC KIT: 2-LUMEN 7 FR X 16 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9694043
• MDR Text Key: 178595056
• Report Number: 9680794-2020-00081
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: CA-22702
• Device Lot Number: 13F19B0482
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.