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

Catalog Number MRC0001MP

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

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

Event Date 04/28/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was received for evaluation.A visual inspection was performed, and it was noted that a particulate was found.During visual inspection, it was also noted that the peel pouch bag pack presented a hole in the paper layer which was large enough for the particulate to pass through.The reported condition was verified.The cause of the reported condition could not be determined.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.

Event Description

It was reported that a plexitron solution administration set presented foreign particles.The issue was identified before use.There was no patient involvement.No additional information is available.

• Brand Name: PLEXITRON SOLUTION ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): 6023865180 EXT 6108; calle 36 no. 2c-22,; apartado aero 2446; cali ; CO
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15160203
• MDR Text Key: 304830265
• Report Number: 1416980-2022-04026
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07707141305553
• UDI-Public: (01)07707141305553
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• 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
• Report Date: 08/03/2022

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: MRC0001MP
• Device Lot Number: SE20DE4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2020
• 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