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

Model Number IPN030243

Device Problem Unsealed Device Packaging (1444)

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

Event Date 03/01/2023

Event Type  malfunction  

Event Description

It was reported the doctor found the kit not sealed properly prior to patient use.No patient involvement with the device was reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4).The customer returned one, opened cvc kit for analysis.No definite signs of use were observed.Visual analysis revealed that the seal was opened and the lidstock was partially separated from the tray.The remnant of the adhesive on the tray is missing from the bottom-left corner of the tray.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 an improperly sealed kit was confirmed through complaint investigation.Visual analysis revealed that the remnants of the seal were missing from the bottom-left corner of the tray.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample 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 doctor found the kit not sealed properly prior to patient use.No patient involvement with the device was reported.

• 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: 17132132
• MDR Text Key: 317253699
• Report Number: 3006425876-2023-00570
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902102536
• UDI-Public: 10801902102536
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K993691
• 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: 05/18/2023

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 Operator: Health Professional
• Device Model Number: IPN030243
• Device Catalogue Number: CV-47702-E
• Device Lot Number: 71F22G2469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• 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