MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-27702-E

Device Problem Unsealed Device Packaging (1444)

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

Event Date 10/20/2022

Event Type  malfunction  

Event Description

It was reported the package seal was found not completely sealed prior to patient use.The device was not used on the patient.

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

(b)(4).The customer returned one cvc kit for analysis.Visual analysis revealed that the bottom-right corner of the lidstock was peeled off the tray, which is not the intended assembly of the lidstock to the tray.Further analysis revealed that the remanence of the glue on the tray was splotchy and not uniform.This likely contributed to the sterility breach reported by the customer.Packaging facility was contacted as part of this complaint investigation.They confirmed that this is a packaging related defect.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use if package is damaged".The report of a sterility issue was confirmed through complaint investigation.Visual analysis revealed that the bottom-right corner of the tray was not sealed properly.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received and the comments from packaging, the root cause for this issue is packaging related.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 package seal was found not completely sealed prior to patient use.The device was not used on the patient.

• Brand Name: ARROW CVC SET: 2-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: 16086143
• MDR Text Key: 306792538
• Report Number: 3006425876-2023-00006
• 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: 12/07/2022

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-27702-E
• Device Lot Number: 71F21L1858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 01/03/2023
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2021
• 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: N/A.; N/A.