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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. DELTEC; PORT &; CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

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SMITHS MEDICAL MD, INC. DELTEC; PORT &; CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Model Number 21-4071-24
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/07/2017
Event Type  malfunction  
Event Description
Sheath was too small to pass the catheter.The two defective devices were given to the manufacture representative.
 
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Brand Name
DELTEC
Type of Device
PORT &; CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL MD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key6892919
MDR Text Key87658726
Report Number6892919
Device Sequence Number1
Product Code LJT
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 09/12/2017,09/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model Number21-4071-24
Device Lot Number87X050
Other Device ID NumberTWO OF THE SAME TYPE OF DEVIC
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/12/2017
Event Location Hospital
Date Report to Manufacturer09/12/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/26/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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