MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number IPN030863

Device Problem Complete Blockage (1094)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that a catheter was inserted.At first use, the distal and central line worked properly, the infusion and the back flow were good.But the proximal line had no back flow and infusion was not going through.The staff only could use 2 lines out of 3.So , the staff had to install an extra line to properly treat the patient before he was transferred to intensive care.

Event Description

It was reported that a catheter was inserted.At first use, the distal and central line worked properly, the infusion and the back flow were good.But the proximal line had no back flow and infusion was not going through.The staff only could use 2 lines out of 3.So , the staff had to install an extra line to properly treat the patient before he was transferred to intensive care.

Manufacturer Narrative

Qn#(b)(4).Additional information was received from the customer indicating "the transfer of the patient to the intensive care unit was independent of the incident.No negative consequence declared following the incident apart from the loss of time." complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and 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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9780474
• MDR Text Key: 181787015
• Report Number: 3006425876-2020-00215
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: IPN030863
• Device Catalogue Number: CV-12853
• Device Lot Number: 71F19E2871
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1