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

Catalog Number CS-27702-E

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

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

Event Date 11/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the package was found "broken" prior to patient use.No patient involvement with device.

Event Description

It was reported the package was found "broken" prior to patient use.No patient involvement with device.

Manufacturer Narrative

(b)(4).The customer returned one, partially opened cvc kit for analysis.The lidstock was opened at the bottom right corner of the tray.The tray was completely sealed in all other locations along the tray.Visual analysis revealed that the tray contained a large crack at the bottom-right corner of the tray.This crack creates a sterility breach in the kit.In addition to the damage, the lidstock was peeled back in the same subsequent area as the damage.It was noted that adhesive residue was observed along the lip of the tray around the opened area.This confirms that the seal between the tray and lidstock was completely intact before it was partially opened.The packaging facility was contacted as part of this complaint investigation.They indicated that all trays are 100% inspected according to manufacturing instructions for molding of trays.Also, all finished goods packaged are 100% inspected after sealing in accordance to manufacturing instructions.They also stated that it appears as if the tray was damaged after the packaging process occurred.Packaging r & d was also contacted as part of this complaint investigation.They indicated that as the lidstock was partially removed in the same area as the crack, it appears as if the damage likely occurred when the kit was being opened; however, as the customer does not mention when they observed the defect, it cannot be determined if this damage occurred before or after the tray was partially opened.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 breach was confirmed through complaint investigation of the returned sample.Visual analysis revealed a large crack in the tray.This crack would have created a breach in the seal.It was also noted that the listock was opened in the same area as the crack in the tray.Confirmation from the packaging facility and packaging r & d confirmed that the trays/kits are 100% inspected for this type of damage.Therefore, the damage likely occurred after the packaging process.Additionally, it cannot be determined if the crack in the tray occurred before or after the tray was partially opened.Therefore, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 13151124
• MDR Text Key: 283146193
• Report Number: 3006425876-2022-00003
• 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: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/11/2022
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F21A0589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2021
• 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