MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI KIT: 9 FR; INTRODUCER CATHETER

Catalog Number AJ-09903

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

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Preliminary investigation confirmed that sample received has scratch marks on the bottom of the tray that matched the customer complaint.However, during that same preliminary investigation, a sterility issue was also observed on the corner of the same tray.

Manufacturer Narrative

Qn#(b)(4).The customer returned one opened psi kit for analysis.Visual examination revealed a small crack in the corner of the tray.White stress marks were identified on all four corners of the tray.Although the tray was previously opened, the tray flange contained evidence of proper sealing.A device history record review was performed, and no relevant findings were identified.The report of a sterility issue was confirmed through complaint investigation.Visual analysis revealed that the bottom-left corner of the tray was cracked.A device history record review was performed, and no relevant findings were identified.Based on the customer description and the sample received, design 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.

Event Description

Preliminary investigation confirmed that sample received has scratch marks on the bottom of the tray that matched the customer complaint.However, during that same preliminary investigation, a sterility issue was also observed on the corner of the same tray.

• Brand Name: ARROW PSI KIT: 9 FR
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8981739
• MDR Text Key: 157144365
• Report Number: 9680794-2019-00355
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K780532
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: AJ-09903
• Device Lot Number: 13F19B0572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1