MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 14 GA X 6" (16 CM); CATHETER PERCUTANEOUS

Catalog Number ES-04706

Device Problems Unsealed Device Packaging (1444); Material Puncture/Hole (1504)

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

Event Date 10/13/2023

Event Type  malfunction  

Event Description

It was reported that: (b)(6) 2023, a hole was found in the package prior to use effecting sterility.There was no patient involvement.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: (b)(6) 2023, a hole was found in the package prior to use effecting sterility.There was no patient involvement.

Manufacturer Narrative

Qn#(b)(4).The customer returned one, unopened cvc kit for analysis.The seal along the outer edge of the lidstock was intact and uniform along the tray.Visual analysis revealed that the kit lidstock and tray contained a sterility breach in the form of two small holes.A third hole on the lidstock was also observed; however, the location of this hole did not create a sterility breach.Microscopic examination confirmed the holes on the lidstock.Slight damage was also observed on the tray.The packaging facility was contacted as part of this complaint investigation.They confirmed that the damage likely occurred after the kit was sealed.Additionally, there is no process step in the packaging process that typically results in the damage observed.The distribution centers (edc rhenus and ap07) were also contacted as part of this complaint investigation.In edc rhenus, they confirmed that this finished good shows no record of repackaging.Likewise, there is no record of this finished good showing such damage during their handling.In ap07, they confirmed that chinese labels are placed on the lidstocks of the kits; however, there is no process that can cause this type of damage.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 that the kit lidstock and tray contained a sterility breach in the form of two small holes.Based on the comments from the packaging facility and the distribution centers for this finished good, this type of damage has not been observed as part of the normal packaging/handling process.Additionally, there are inspections in place to check for such damage.Based on the customer report, the sample received, and the comments from packaging/distribution, storage/shipping likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 14 GA X 6" (16 CM)
• Type of Device: CATHETER PERCUTANEOUS
• 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: 18047957
• MDR Text Key: 327076075
• Report Number: 3006425876-2023-01125
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902108418
• UDI-Public: 00801902108418
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K862056
• 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: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ES-04706
• Device Lot Number: 71F22F1708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• 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
• Treatment: NOT REPORTED.; NOT REPORTED.