MAUDE Adverse Event Report: CAREFUSION AS LVP 20D 3SS CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 2426-0007

Device Problems Complete Blockage (1094); Leak/Splash (1354); Difficult to Remove (1528); Difficult or Delayed Separation (4044)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 3ss cv was difficult to connect.This causes damaged, flow issues, and leakage.The following information was provided by the initial reporter: material no.: 2477-0007 ; batch no.: 20045670.It was reported when connecting the male lure end of the tubing to a hot line, it requires more strength creating a sense that the connection is unstable or leading to over-tightening.The or have been experiencing some problems with bd tubing compatibility to the smiths medical tubing for the fluid warmers.The problem occurs with both the blood tubing and.

Event Description

It was reported that as lvp 20d 3ss cv was difficult to connect.This causes damaged, flow issues, and leakage.The following information was provided by the initial reporter: material no.: 2477-0007 batch no.: 20045670 it was reported when connecting the male lure end of the tubing to a hot line, it requires more strength creating a sense that the connection is unstable or leading to over-tightening.The or have been experiencing some problems with bd tubing compatibility to the smiths medical tubing for the fluid warmers.The problem occurs with both the blood tubing and.

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaint of difficult connection with maxzero male luer could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.A device history record review for model 2426-0007 lot number 20055799 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 11may2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model mz9267 lot number 20037349 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 29mar2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this maxzero.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h10.

• Brand Name: AS LVP 20D 3SS CV
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10518302
• MDR Text Key: 207531998
• Report Number: 9616066-2020-02665
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• 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: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 20055799
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100, 8015,; 8100, 8015,
• Patient Outcome(s): Other