MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number CU-22122-F

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

Patient Problem No Patient Involvement (2645)

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports that there was an obvious gap on the package during incoming inspection.

Event Description

The customer reports that there was an obvious gap on the package during incoming inspection.

Manufacturer Narrative

Qn#(b)(4).The customer returned one, unopened hemodialysis kit for analysis.All the kit contents appeared to be present within the tray.Visual analysis revealed a hole/sterility breech on the contour tray.Microscopic examination revealed that the tray around the hole is warped.In addition to this, an unknown, black material was also observed.The appearance of this sterility breach appears consistent with damage as a result of the tray being burned likely during the storage and shipping process.The packaging facility was contacted as part of this complaint investigation.They confirmed that the kit likely came in contact with a heat source, causing the tray to melt.They also indicated that this defect could not have occurred during the packaging process.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.The report of a sterility issue was confirmed through complaint investigation.Visual analysis revealed a hole on the contour tray.Likewise, microscopic examination revealed that the area around the hole was deformed/warped, and a black foreign material was observed.This indicates that the hole was likely caused by an unknown heat source.Based on the customer report and the comments from the packaging facility, the root cause for this complaint is storage and shipping.Teleflex will continue to monitor and trend for report of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9916319
• MDR Text Key: 186213064
• Report Number: 3006425876-2020-00303
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• 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: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/29/2021
• Device Catalogue Number: CU-22122-F
• Device Lot Number: 71F19H0338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1