MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW - CVC SET; CATHETER, PERCUTANEOUS

Catalog Number VASCULAR UNKNOWN

Device Problems Obstruction of Flow (2423); Material Deformation (2976); Material Too Soft/Flexible (4007)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog number and lot number unknown at the time of this report.Awaiting additional information to confirm catalog and lot number.

Event Description

The customer reports several incidents of the lines kinking and obstructing the flow of noradrenaline having an impact on the patients.The customer notes the kinking below the hub and above the skin.They noted that when the catheter body got very warm it became very malleable.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed because a sample was returned for analysis.A device history record review could not be performed as a product code and lot number were not provided.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports several incidents of the lines kinking and obstructing the flow of noradrenaline having an impact on the patients.The customer notes the kinking below the hub and above the skin.They noted that when the catheter body got very warm it became very malleable.

• Brand Name: ARROW - CVC SET
• Type of Device: CATHETER, PERCUTANEOUS
• 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 ; 9194334854
• MDR Report Key: 7856760
• MDR Text Key: 119647941
• Report Number: 3006425876-2018-00618
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VASCULAR UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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