MAUDE Adverse Event Report: BECTON DICKINSON CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Device Alarm System (1012); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2021

Event Type  Injury  

Event Description

A (b)(6) (midas number (b)(6)): patients call bell was going off, went into room, iv tubing was on floor, mother stated her tubing just fell off from the patient.Tubing disconnected where tubing connected to patient.Fda safety report id # (b)(4).

• Brand Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 12287717
• MDR Text Key: 265646338
• Report Number: MW5103056
• Device Sequence Number: 2
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 MO