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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOSPIRA, INC. LIFESHIELD; IV TUBING EXTENSION
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HOSPIRA, INC. LIFESHIELD; IV TUBING EXTENSION Back to Search Results
Lot Number 66132NS
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/06/2017
Event Type  malfunction  
Event Description
Iv therapy nurse reports that patient was being assessed for new piv site in the right arm.No current peripheral iv's or medications infusing in the right upper extremity.Accessed vein in right forearm without difficulty with #22 gauge angio.Attached newly opened saline lock, aspirated blood and flushed with 10 ml ns.Saline lock was in sealed package prior to connection with no obvious abnormalities.Post flush and clamping of saline lock, there was a gray particulate matter that appeared internally within the saline lock tubing.Site was assessed by another rn and the saline lock was promptly removed and replaced with new saline lock, aspirated, and flushed with 10 ml ns without incident.
 
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Brand Name
LIFESHIELD
Type of Device
IV TUBING EXTENSION
Manufacturer (Section D)
HOSPIRA, INC.
highway 301 north
rocky mount NC 27801
MDR Report Key6360201
MDR Text Key68371731
Report Number6360201
Device Sequence Number1
Product Code FPK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Lot Number66132NS
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/06/2017
Event Location Hospital
Date Report to Manufacturer02/06/2017
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 Number1
Treatment
NO OTHER THERAPIES
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