MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAP

Catalog Number CDC-45703-P1A

Device Problem Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2023

Event Type  malfunction  

Event Description

It was reported the patient presented to the hospital on (b)(6) 2023 with the central line in place.Patient was sent for a ct scan and when they injected the contrast at 5ml/sec the tubing started to swell down near the dressing.They stopped the test and removed the catheter.A different pressure injectable catheter was placed and test proceeded.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient presented to the hospital on (b)(6) 2023 with the central line in place.Patient was sent for a ct scan and when they injected the contrast at 5ml/sec the tubing started to swell down near the dressing.They stopped the test and removed the catheter.A different pressure injectable catheter was placed and test proceeded.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of extension line stretched was able to be confirmed by the photo.A complete visual inspection could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "precaution: to minimize the risk of damage to extension lines from excessive pressure, each clamp must be opened prior to infusing through that lumen".The customer supplied photo displayed parameters stating "5ml/sec" and "300psi".According to the pressure injection info card provided with this kit, the maximum indicated pressure injection flow rate for the medial extension line is 5ml/sec.R & d also consulted that "if the customer set the injection machine to provide a required flow rate of 5ml/sec, regardless of pressure, the pressure could rise to whatever is necessary to achieve the flow, which may lead to catheter ballooning or bursting".Based on the customer photo, it appears as though the pressure was set to 300 psi which is within the indicated range.The customer report of extension line stretched/ballooned could be confirmed by visual inspection of the customer supplied photo.The image showed an extension line of the catheter ballooned/stretched which appears consistent with damage related to overpressure.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16852430
• MDR Text Key: 314359709
• Report Number: 9680794-2023-00305
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CDC-45703-P1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 06/06/2023
• Supplement Dates FDA Received: 06/07/2023
• 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
• Treatment: NOT REPORTED.; NOT REPORTED.