MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 30CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number EU-24703-CVT

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Additional information: this product is not sold in the us.The 510k # provided is for a similar product that is sold in the us.

Event Description

The customer reports that it was noted the lumen of the device twisted and ballooned.

Manufacturer Narrative

(b)(4).The customer returned a 3-lumen cvc catheter for evaluation.The catheter showed obvious signs of use in the form of biological material and sutures on the box clamps.The catheter body was cut 263mm from the juncture hub.The other portion of the catheter was not returned for investigation.No other components were returned.Visual examination revealed that the medial extension line (blue hub) was stretched/ballooned across most of the extension line body.The luer hubs of the catheter did not have pressure injection markings indicating the catheter is not for high pressure injection applications.Dried blood was observed within the extension line indicating the line had been used.Visual examination of the other two extension lines did not reveal and defects or anomalies.The catheter body was cut 263mm from the juncture hub.The distal extension line was flushed with water using a lab inventory 10ml syringe and no blockages was observed.Water flushed out of the catheter tip with minimal resistance.No inter lumen crossover was observed.The customer did not supply a lot number; however, a potential lot number was determined from a sales history review for this customer.A device history record review was performed on the catheter from the potential lot and no relevant manufacturing issues were identified.The ifu supplied with the kit cautions the user to "only utilize catheters indicated for high pressure injection applications for such applications.Utilizing catheters not indicated for high pressure applications can result in inter-lumen crossover or rupture with potential for injury." the ifu also warns to "open catheter clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." the customer report of the medial extension line stretching/ballooning was confirmed through evaluation of the returned sample.The medial extension line was stretch/ballooned for most of the extension line body.No blockages or leaks were observed while functionally testing the catheter during investigation.The returned catheter was not indicated for pressure injection and the ifu supplied with this kit cautions to only utilize catheters indicated for high pressure injection applications for such applications.Based on the customer report and the condition of the returned sample, it was determined that unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports that it was noted the lumen of the device twisted and ballooned.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 30CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8124415
• MDR Text Key: 129040632
• Report Number: 3006425876-2018-00774
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• 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: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: EU-24703-CVT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Date Manufacturer Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1