MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI KIT: 8.5 FR; CATHETER, INTRODUCER

Catalog Number MTO-09801-CHA

Device Problems Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: when the tray was opened, it was cracked and broken.

Manufacturer Narrative

(b)(4).The customer returned one semi-opened psi kit for analysis.Visual inspection revealed that the bottom right corner of lidstock was partially opened.A piece of the tray had broken off and was still attached to the lidstock.A crack was also observed near the broken section of the tray.No signs of use were identified in the kit contents.A device history record review was performed and no relevant findings were identified to indicate a manufacturing related cause.The customer complaint of a damaged tray was confirmed through complaint investigation of the returned sample.Visual examination revealed that the kit was partially opened, and a portion of the tray had broken off and was still attached to the lidstock.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.Based on the sample received and the customer description, the root cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: when the tray was opened, it was cracked and broken.

• Brand Name: ARROW PSI KIT: 8.5 FR
• Type of Device: CATHETER, INTRODUCER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8296806
• MDR Text Key: 134732735
• Report Number: 9680794-2019-00040
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K993691
• 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: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: MTO-09801-CHA
• Device Lot Number: 13F18K0869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1