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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PROTECT IV PLUS; CATHETER, INTRAVASCULAR, THERAPEUTIC
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SMITHS MEDICAL ASD, INC. PROTECT IV PLUS; CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number 3063
Device Problems Flushing Problem (1252); Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/24/2017
Event Type  malfunction  
Event Description
It is unsure when the catheter actually broke away from the hub as the rn discovered when attempting a routine flush of the catheter, and it would not flush.She then took down the dressing and upon removal of the iv, only the hub was removed; no catheter was attached to it.X-ray confirmed tubular radiopaque foreign body present about the second metacarpal.It was surgically removed the following day.
 
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Brand Name
PROTECT IV PLUS
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
MDR Report Key6646488
MDR Text Key77731695
Report Number6646488
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/30/2019
Device Catalogue Number3063
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/26/2017
Event Location Hospital
Date Report to Manufacturer05/26/2017
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
OTHER, DAILY NORMAL SALINE FLUSHES OF THE CATHET; THE IV CATHETER WAS COVERED BY A DRESSING, AND ATT
Patient Outcome(s) Other;
Patient Age68 YR
Patient Weight100
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