MAUDE Adverse Event Report: BD / BECTON DICKINSON AND COMPANY BD SECONDARY SET; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number (10)23059177

Patient Problem Chemical Exposure (2570)

Event Type  malfunction  

Event Description

Nurse took cyclophosphamide chemotherapy out of bag with secondary set, hung up on iv pole and then noticed she was holding the secondary tubing, with the chemotherapy bag and drip chamber on the iv pole spilling chemotherapy.Tubing severed just below drip chamber.3 nurses aided in spill cleanup.

• Brand Name: BD SECONDARY SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD / BECTON DICKINSON AND COMPANY
• MDR Report Key: 18075360
• MDR Text Key: 327590722
• Report Number: MW5147803
• 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: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/31/2023

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 Lot Number: (10)23059177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White