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U.S. Department of Health and Human Services

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

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CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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).
 
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Brand NameCLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12287717
MDR Text Key265646338
Report NumberMW5103056
Device Sequence Number2
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 08/04/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/05/2021 Patient Sequence Number: 1
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