MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 4-LUMEN 8.5FR X 16CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CS-42854-HP

Device Problems Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: packaging of product has a hole in the blue plastic tray and was covered in a saw-dust type light colored powder.Customer said that there was a hole in the outer cardboard box that correlates to where the hole in the blue plastic tray was.

Event Description

The customer reports: packaging of product has a hole in the blue plastic tray and was covered in a saw-dust type light colored powder.Customer said that there was a hole in the outer cardboard box that correlates to where the hole in the blue plastic tray was.

Manufacturer Narrative

(b)(4).The customer returned one opened cs-42854-hp kit for analysis.Visual analysis of the returned sample revealed a hole on the back of the kit tray.Two other dents were observed near the hole; however, they did not puncture completely through the tray.In addition to the damage on the tray, foreign particles were discovered all over the exterior and interior of the kit.This foreign material appeared consistent to wood shavings.Packaging was consulted to determine a root cause for this complaint issue.They stated that there is no possibility that the damage to the outer tray was caused at their facility.Hence, they believe that this is a storage and shipping related issue.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.The report of a sterility issue in the kit packaging was confirmed through complaint investigation.Visual analysis revealed a puncture hole on the back of the kit tray.Additionally, a foreign material that appeared similar to saw dust was observed all over the exterior and interior of the kit.Packaging was contacted to determine a root cause.They stated that the damage to the outer tray did not occur at their facility.A device history record review was performed with no relevant findings.Based on the customer description, the response from the packaging facility, and the sample received, storage and shipping likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC KIT: 4-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8658845
• MDR Text Key: 146667170
• Report Number: 3006425876-2019-00393
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/10/2021
• Device Catalogue Number: CS-42854-HP
• Device Lot Number: 71F19C0806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1