MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SOLUTION SET WITH DUO-VENT SPIKE; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number (10)R17A03102

Device Problem Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 09/13/2017

Event Type  malfunction  

Event Description

Chemo was found leaking from tubing at y junction where remicade meets nss.Nss was running at kvo and was attached to patient and remicade was connected at y site.Fluid was found on floor (approximately 30-40 cc).Chemo spill kit was opened and spill was cleaned and disposed of per policy and directions in kit.Patient had one or two drops of fluid on his hand, otherwise they were not exposed to spill on clothing or shoes.

• Brand Name: SOLUTION SET WITH DUO-VENT SPIKE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 911 north davis; cleveland MS 38732
• MDR Report Key: 7006346
• MDR Text Key: 91249572
• Report Number: 7006346
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: (10)R17A03102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CHEMOTHERAPY
• Patient Age: 77 YR