MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Catalog Number CV-12854

Device Problem Material Twisted/Bent (2981)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Date 03/21/2024

Event Type  Injury  

Manufacturer Narrative

Qn # (b)(4).

Event Description

It was reported "the proximal tubing of the central line, close to the patient, kinked.Noradrenaline was being administered, which caused arterial hypotension for a time.After a few minutes, the syringe pump started beeping.After investigating, we realised when handling the catheter that it was kinked.When we un-kinked it, a bolus of nad was administered, with severe hypertension." the patient's current condition is reported as "unknown".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.No relevant findings were identified.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

It was reported "the proximal tubing of the central line, close to the patient, kinked.Noradrenaline was being administered, which caused arterial hypotension for a time.After a few minutes, the syringe pump started beeping.After investigating, we realised when handling the catheter that it was kinked.When we un-kinked it, a bolus of nad was administered, with severe hypertension." the patient's current condition is reported as "unknown".

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19214980
• MDR Text Key: 341414166
• Report Number: 3006425876-2024-00373
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801902029239
• UDI-Public: 10801902029239
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CV-12854
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2024
• 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: NONE REPORTED.; NONE REPORTED.