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

Model Number 11522558

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.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 bv had air in the line.The following information was provided by the initial reporter: it was reported by the customer that they have 2 more tubing issues.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-06-21.H6: investigation summary one sample (model #11522558) was returned from the customer.It was reported that there are air in line issues with the tubing.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed successfully with saline.After priming, the set was drained to see where the ball would land in the drip chamber.The ball landed where it should at the bottom of the drip chamber and did not allow air in the line.The failure was unable to be replicated, and the complaint could not be verified.A root cause was unable to be determined because the failure was unable to be replicated.A device history record review for model 11522558 lot number 20116057 was performed.The search showed that a total of 11,523 units in 1 lot number was built on 20nov2020.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.H3 other text : see h10.

Event Description

It was reported that as lvp 20d 3ss cv bv had air in the line.The following information was provided by the initial reporter: it was reported by the customer that they have 2 more tubing issues.

• Brand Name: AS LVP 20D 3SS CV BV
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12112074
• MDR Text Key: 260089798
• Report Number: 9616066-2021-51449
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403232303
• UDI-Public: 50885403232303
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• 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: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 11522558
• Device Catalogue Number: 11522558
• Device Lot Number: 20116057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• 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