MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C6226
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250); Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone no.- (b)(6).G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity of extension sets leaked.The event occurs after the user attached the extension tubing to the patient¿s peripheral iv (catheter hub).The iv tubing separates from the catheter hub and subsequently leaks at the separation of the connectors.This leak would then prevent the full volume of medication from being infused.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H11: the actual device was not available; however, a photograph of the sample packaging was provided for evaluation.The returned photograph was reviewed, and it was noted that the picture was of the labeling on the packaging.The photograph could not refute or verify the reported condition.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: EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19352208
• Report Number: 1416980-2024-02371
• Device Sequence Number: 7232762
• Product Code: FPA
• UDI-Device Identifier: 00085412003900
• UDI-Public: (01)00085412003900
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 2C6226
• Device Lot Number: R23I28123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/24/2024
• Date Device Manufactured: 09/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown