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

Catalog Number EMC7109

Device Problem Crack (1135)

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

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter first name: initial reporter last name: initial reporter facility name: initial reporter address: initial reporter city: should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the connector of a two (2) female luer lock adapters with control-a-flo were cracked.The issue was identified during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The lot was manufactured in february 2021.The actual devices were not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the photograph which showed a crack at the female connector.The reported condition was verified.The cause of the condition was due to a supplier related 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: I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - TUNISIA; route de chebbaou; 2021oued e; tunis ; TS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15427899
• MDR Text Key: 301244160
• Report Number: 1416980-2022-04843
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05413760192321
• UDI-Public: (01)05413760192321
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EMC7109
• Device Lot Number: 21B03T430
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: No
• 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