MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number CS-12122-E

Device Problems Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the package was not sealed completely.The issue was detected prior to patient use.

Manufacturer Narrative

Qn# (b)(4).The customer returned an opened cs-12122-e kit for evaluation.Visual examination of the sample revealed that the lidstock is taped down.Once the tape was removed, only the top of the kit remained sealed.The tray flange was examined and there is adhesive transfer where the pouch 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.Packaging engineering for this kit was contacted to further evaluate the sample.The engineers concluded that based on the fact there is adhesive transfer along the pouch, the opened portion is most likely not caused by a manufacturing issue.The initial condition of the seal could not be determined based on the fact that the set was returned opened; however, there are no indications that the initial seal was faulty.A device history record review was performed with no manufacturing issues identified.The customer's reported complaint of a sterility issue could not be confirmed based on the sample received.The customer returned an opened set for evaluation.The tray flange was examined and there is adhesive transfer where the kit was unsealed.There are no gaps in the adhesive transfer and it appears the kit was once properly sealed along the border of the tray flange.A device history record review was performed, and no manufacturing issues were identified.The packaging engineers for this kit were contacted to further evaluate the sample.The engineers concluded that because there is adhesive transfer along the tray flange, the opened portion is mostly likely not caused by a manufacturing issue.Based on the sample received and information provided by the manufacturing facility, the probable cause of this issue could not be determined.

Event Description

The customer reports that the package was not sealed completely.The issue was detected prior to patient use.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8650843
• MDR Text Key: 146398183
• Report Number: 3006425876-2019-00380
• 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: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: CS-12122-E
• Device Lot Number: 71F16H0853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Date Manufacturer Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1