MAUDE Adverse Event Report: CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number AMC9668

Device Problem Backflow (1064)

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

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was backflow of unspecified solution while using a continu-flo solution set.This was observed during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed including leak testing and gravity testing which revealed a blockage at level of junction tube/nypro check valve.The reported condition was verified.The cause of the condition was due to manufacturing related issue.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12475953
• MDR Text Key: 271526991
• Report Number: 1416980-2021-05744
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05413765578038
• UDI-Public: (01)05413765578038
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• 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: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AMC9668
• Device Lot Number: 21A15T108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2021
• 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
• Treatment: NA.