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

Catalog Number ES-04706

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that the logistics center found cracks on the edges of the tray.

Manufacturer Narrative

(b)(4).The customer returned one opened cvc kit for investigation.The time stamp on the lid stock read #2129072.Visual examination of the returned sample revealed the lidstock was partially separated along three sides of the finished kit.The tray flange was examined and there is adhesive transfer where the kit is currently unsealed.There are no gaps in the adhesive transfer and it appears as though the kit was once properly sealed along the border of the tray flange.No cracks were found on the tray.No other defects were detected.Packaging engineering was consulted as part of this investigation.According to the packaging engineer, there is evidence of a sufficient seal and adhesive transfer, which would prevent a sterile barrier breach.No issues could be found with the seal.It is possible that the kit was opened by a user at the hospital and then placed back into inventory.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "sterile, single use: do not reuse, reprocess o r re-sterilize.Reuse of device creates a potential risk of serious injury and/or infection which may lead to death." the customer report of a broken seal could not be confirmed by complaint investigation of the returned sample.According to the packaging engineer, there is evidence of a sufficient seal and adhesive transfer, which would prevent a sterile barrier breach.No issues could be found with the seal.A device history record review was performed and no relevant findings were identified.It is possible that the kit was opened by a user at the hospital and then placed back into inventory.However, this could not be confirmed.Therefore, the probable cause of this complaint could not be determined as it is unknown when the sterility breach occurred.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that the logistics center found cracks on the edges of the tray.

• Brand Name: ARROW CVC SET: 14 GA X 6" (16 CM)
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10546195
• MDR Text Key: 207315713
• Report Number: 3006425876-2020-00842
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/12/2024
• Device Catalogue Number: ES-04706
• Device Lot Number: 71F19C0513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1