MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Catalog Number FR-45854-IPSE

Device Problem Migration (4003)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the catheter was properly attached at the level of the luer hub and secured with a tegaderme.While the staff member was working on the patient at one stage, the nurse noticed that the catheter was moving through the blue wings of the hub and that the catheter was almost totally out of the puncture point attachment.Clinical consequences: the patient was currently under catecholamines to maintain his blood pressure.As the catheter went out of the vein, the patient had his blood pressure severely decreasing.The user managed very quickly to change the catheter and move it in another venous line.

Manufacturer Narrative

Qn# (b)(4).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.

Event Description

It was reported that the catheter was properly attached at the level of the luer hub and secured with a tegaderme.While the staff member was working on the patient at one stage, the nurse noticed that the catheter was moving through the blue wings of the hub and that the catheter was almost totally out of the puncture point attachment.Clinical consequences: the patient was currently under catecholamines to maintain his blood pressure.As the catheter went out of the vein, the patient had his blood pressure severely decreasing.The user managed very quickly to change the catheter and move it in another venous line.

• Brand Name: ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8902254
• MDR Text Key: 154624976
• Report Number: 3006425876-2019-00601
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• 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: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2021
• Device Catalogue Number: FR-45854-IPSE
• Device Lot Number: 71F19D2914
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 09/19/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention