MAUDE Adverse Event Report: AS LVP 20D; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 10942011

Device Problem Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2021

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 had foreign matter.The following information was provided by the initial reporter: material #: (b)(4), batch/lot #: 20116931.It was reported that the drip chamber appeared cloudy or "dirty".

Manufacturer Narrative

H.6.Investigation: one sample was received for quality investigation.The customer complaint of foreign matter-other-dirty was verified by visual inspection.Evaluation of the sample showed that the drip chamber had a cloudy appearance to it.Further observation of the drip chamber revealed a crack at the bottom of the drip chamber.The cloudiness of the drip chamber seem to originate from the crack in the drip chamber.A device history record review for model 10942011 lot number 20116931 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the issue seen in this complaint could not be fully determined.The sample cloudiness seen in the drip chamber seems to have been caused due to a crack at the bottom of the drip chamber.The sample was sent to the supplier for further investigation and root cause analysis.The supplier indicated that the cloudiness was verified, however the drip chamber was perfectly junketed and no leak observed as indicated by the supplier investigation memo.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of foreign matter - dirty with lot #20116931 regarding item #10942011.

Event Description

It was reported that as lvp 20d had foreign matter.The following information was provided by the initial reporter: material #: 10942011; batch/lot #: 20116931.It was reported that the drip chamber appeared cloudy or "dirty".

• Brand Name: AS LVP 20D
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 11868118
• MDR Text Key: 252243176
• Report Number: 9616066-2021-51118
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232404
• UDI-Public: 10885403232404
• Combination Product (y/n): N
• PMA/PMN Number: K931173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/26/2023
• Device Catalogue Number: 10942011
• Device Lot Number: 20116931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Date Manufacturer Received: 08/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2020
• 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