MAUDE Adverse Event Report: .V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number EMC7109

Device Problems Fluid/Blood Leak (1250); Device Damaged Prior to Use (2284)

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

Event Date 08/20/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of two female luer lock adapters with control-a-flo were damaged which resulted in leakage.This issue was identified before patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction made to d1: brand name: i.V.Administration sets with control-a-flo regulator (previously submitted as.V.Administration sets with control-a-flo regulator) additional information was added to d9, h3, h4, h6 and h10.One (1) actual sample was received for evaluation.A visual inspection was performed and a crack was observed at the female connector.Functional testing was not performed for this complaint.The reported condition was verified.The cause of the condition was due to a manufacturing 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: .V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12465735
• MDR Text Key: 271224219
• Report Number: 1416980-2021-05652
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05413760192321
• UDI-Public: (01)05413760192321
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: EMC7109
• Device Lot Number: 19C15T738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2019
• 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