MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VALVE SET, EM2400; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number H938724

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter last name: (b)(6), e1: initial reporter facility name - (b)(6), e1: initial reporter phone no.- (b)(6), e1: initial reporter e-mail - (b)(6), should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that foreign matter contamination was observed on an em2400 valve set.The foreign matter was described as, ¿a greasy film remains on the glove after handling¿.This issue was observed prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufactured on december 04, 2021- december 06, 2021.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VALVE SET, EM2400
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• 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 60073 ; 2242702068
• MDR Report Key: 17317814
• MDR Text Key: 318984938
• Report Number: 1416980-2023-03536
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 00085412477183
• UDI-Public: (01)00085412477183
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

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: 60420102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/17/2023
• 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