MAUDE Adverse Event Report: CAREFUSION AS LVP 20D DEHP 2SS CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 2420-0500

Device Problems Component Missing (2306); Free or Unrestricted Flow (2945)

Patient Problem No Patient Involvement (2645)

Event Date 07/24/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that as lvp 20d dehp 2ss cv tubing was missing the roller clamp.The following information was provided by the initial reporter: material no: 2420-0500, batch no: unknown.It was reported that tubing was missing roller clamp.

Manufacturer Narrative

The customer's report of a missing roller clamp was confirmed based on the customer provided sample.The sample showed an absence of the roller clamp component on a used set.A sample has been received and the root cause was identified as a misassembly of the set during the manufacturing process.A device history record review for model 2420-0500 lot number 20053015 was performed.The search showed that a total of 34563 units in 1 lot number was built on 08may2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that as lvp 20d dehp 2ss cv tubing was missing the roller clamp.The following information was provided by the initial reporter: material no:2420-0500 batch no: unknown it was reported that tubing was missing roller clamp.

• Brand Name: AS LVP 20D DEHP 2SS CV
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10467695
• MDR Text Key: 204927379
• Report Number: 9616066-2020-02581
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: 7613203012430
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/08/2023
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Device Lot Number: 20053203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 20200724; 20200724
• Patient Outcome(s): Other