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

Catalog Number EMC9608

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/05/2023

Event Type  Injury  

Event Description

It was reported that during an intravenous (iv) infusion with a solution administration set, the patient "sat up and pulled something found bleeding".It was further reported that "on inspection", the set was noted to be damaged ("snapped"), and blood from the central venous catheter back tracked onto bed.There was no report of medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device was not available for evaluation; however, two retention samples were evaluated.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All junctions underwent a push-pull test, and no disconnections were identified.The samples were leak tested underwater and air passage testing was performed.No leaks were identified, and no blockages were found.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 SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18113834
• MDR Text Key: 327878346
• Report Number: 1416980-2023-05841
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EMC9608
• Device Lot Number: 23F14V846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• 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
• Patient Outcome(s): Other