MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25703-E

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the seal of the package was found open prior to patient use, in the clinical setting.No patient involvement with the device was reported.

Manufacturer Narrative

(b)(4).The customer provided one image for analysis.Visual analysis revealed that the kit lidstock was not properly sealed over the top left corner of the tray.The customer also returned one cvc kit for analysis.No definite signs of use were observed on any of the kit components.Visual analysis revealed that the seal at the top-left corner of the tray was defective.The remnants of the seal were not visible on the tray.Further analysis revealed that the seal appeared to be adhered to the lidstock.The seal appeared to be intact in all other part of the kit.A device history record review was performed, and no relevant findings were identified.The report of a sterility breach was confirmed through complaint investigation.Visual analysis revealed that the seal at the top left corner of the tray was defective.No remnants of the seal were located on the tray; however, it appeared to be adhered to the lidstock.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample as received, packaging caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported the seal of the package was found open prior to patient use, in the clinical setting.No patient involvement with the device was reported.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16544648
• MDR Text Key: 311300906
• Report Number: 3006425876-2023-00292
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

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 Expiration Date: 10/31/2023
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F21L1187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED