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

Catalog Number AJ-09801

Device Problems Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Preliminary evaluation of the returned device indicates a sterility issue.

Event Description

It was reported that when the user tried to open the kit, that is, began to peel off the tyvek, the tray got broken at the adhered surface to the tyvek.

Event Description

It was reported that when the user tried to open the kit, that is, began to peel off the tyvek, the tray got broken at the adherend surface to the tyvek.

Manufacturer Narrative

Qn#(b)(4).The customer returned one, opened psi kit for analysis.Despite the customer removing the lidstock, the inner tray had not been opened as the csr wrap was still intact.Visual analysis of the returned kit revealed that the bottom-right and the bottom-left corners of the tray contained a crack.Stress marks were also identified around the edges of the cracks.A device history record review was performed, and no relevant findings were identified.The report of a defective tray was confirmed through complaint investigation.The lidstock was opened; however, the inner tray and csr wrap were left untampered.Visual analysis revealed that the bottom-right and bottom-left corners of the tray were cracked.Additionally, 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.

• Brand Name: ARROW PSI KIT: 8.5 FR
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9897069
• MDR Text Key: 185494126
• Report Number: 9680794-2020-00176
• 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: 03/27/2020

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: No Information
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: AJ-09801
• Device Lot Number: 13F19C0058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: 03/27/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1