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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOSPIRA, INC. PLUM SET, ADMINISTRATION, INTRAVASCULAR

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HOSPIRA, INC. PLUM SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 1194802
Device Problems Device Slipped (1584); Chemical Spillage (2894)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/09/2018
Event Type  malfunction  
Event Description
The clear flexible tubing that goes into the spike slid out of the spike causing tpn to spill. When i place the flexible tubing back into the bottom of the spike, it pulls out very easily. The device was retained however packing as disposed of. This did not negatively impact the patient.
 
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Brand NamePLUM
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
HOSPIRA, INC.
highway 301 north
rocky mount NC 27801
MDR Report Key7442745
MDR Text Key105908379
Report Number7442745
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1194802
Device Catalogue Number1194802
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/10/2018
Event Location Hospital
Date Report to Manufacturer04/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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