MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VALVE SET, EM2400; SET, I.V. FLUID TRANSFER

Catalog Number H938724

Device Problem Material Discolored (1170)

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

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

Additional initial reporter phone no.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified quantity of empty nutrition bags were discolored.The discoloration was further described as, ¿appearing cloudy¿.These issues were identified prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B5: upon further investigation, it was determined that the affected products were two (2) em2400 valve sets, previously submitted as ¿an unspecified quantity of empty nutrition bags¿.The nutrition bas appeared cloudy as the valve sets were leaking unintended ingredients through the fluid path and into the bags.D1: the correct brand name is ¿valve set, em2400¿, previously submitted ¿ni¿.D4: the correct catalogue # is ¿h938724¿, previously submitted as ¿asku¿.D4: the correct lot # is ¿60333005¿, previously submitted as ¿asku¿.D4: the udi # is ¿(01)00085412477183¿, previously submitted as ¿ni¿.G4: 510k #: the correct # is ¿k002705¿, previously submitted as ¿ni¿.H4: the lot was manufactured from november 17, 2021 ¿ november 18, 2021.H10: should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VALVE SET, EM2400
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): AVAILMED; c. industrial lt. 001 mz. 105; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14043834
• MDR Text Key: 288804059
• Report Number: 1416980-2022-01641
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477183
• UDI-Public: (01)00085412477183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2022

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
• Device Operator: Other
• Device Catalogue Number: H938724
• Device Lot Number: 60333005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/07/2022
• Supplement Dates Manufacturer Received: 05/03/2022; 05/18/2022
• Supplement Dates FDA Received: 05/07/2022; 05/21/2022
• 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