MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7FR X 60CM; CATHETER, PERCUTANEOUS

Catalog Number JP-17752-C

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Potential lot# 71f18c3170.The product (catalog#) is not intended for sale in the us.Similar product/component sold in the us.

Event Description

It was reported that the hub along with injection cap came off while in use.Therefore, it was replaced with a new kit.According to the user, the catheter might have been pulled or hit by something before the cap came off.

Manufacturer Narrative

Qn# (b)(4).The customer returned a cvc set: 2-lumen 7fr x 60cm catheter for investigation.Visual inspection of the returned catheter revealed the distal extension line luer hub was separated from the catheter.The catheter also showed significant signs of use in the form of biological material.Microscopic examination revealed part of the distal extension line was still inside the luer hub.The point of separation was rough and jagged indicating excessive force caused the breakage.The inner and outer diameter of the distal extension line were measured and were found to be within specification.This indicates there is no wall thickness issue.A manual tug test confirmed the remaining extension line was fully secured within the luer hub.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with the kit warns the user "do not apply excessive force in removing guide wire or catheter.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained, and further consultation requested." the customer report of a separated luer hub was confirmed by complaint investigation.Visual inspection of the returned catheter revealed the distal extension line luer hub was separated from the catheter.Microscopic examination revealed part of the distal extension line was still inside the luer hub.The point of separation was rough and jagged indicating excessive force caused the breakage.The extension line passed all relevant dimensional inspection and a device history record review was performed with no relevant findings to suggest a manufacturing related issue.Based on the report that this event occurred during use, it was determined that unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that the hub along with injection cap came off while in use.Therefore, it was replaced with a new kit.According to the user, the catheter might have been pulled or hit by something before the cap came off.

• Brand Name: ARROW CVC SET: 2-LUMEN 7FR X 60CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8256468
• MDR Text Key: 133334790
• Report Number: 3006425876-2019-00045
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• 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: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: JP-17752-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1