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

Catalog Number FNC6241

Device Problems Disconnection (1171); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a solution set was missing the ¿tip¿; further described as ¿where med exchanged and there was no tip¿.This was identified during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added.Expiration date: 3/2023.One actual sample was received for evaluation.A visual inspection was performed using the naked eye which revealed that the two (2) piece luer lock was missing.Functional testing was not performed for this complaint.The reported condition was verified during the initial inspection.The cause of the reported condition was determined to be a manufacturing related issue occurring during the automated assembly process.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: SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9363822
• MDR Text Key: 168914035
• Report Number: 1416980-2019-06487
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412056241
• UDI-Public: (01)00085412056241
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: FNC6241
• Device Lot Number: SR18C02044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1