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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC PORT-A-CATH II POWER P.A.C; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS,INTRAVASCULAR, PRODUCT CODE: LJT
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SMITHS MEDICAL ASD, INC. DELTEC PORT-A-CATH II POWER P.A.C; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS,INTRAVASCULAR, PRODUCT CODE: LJT Back to Search Results
Catalog Number 21-4455-24 
Device Problems Loose or Intermittent Connection (1371); Material Separation (1562); Defective Device (2588)
Patient Problem No Information (3190)
Event Date 05/01/2019
Event Type  Injury  
Event Description
Information was received that a "defective" smiths medical deltec port-a-cath ii power p.A.C port-a-cath had to be removed from the patient after an x-ray.No adverse effects were reported.
 
Manufacturer Narrative
One deltec power port-a-cath ii port was returned to smith medical for investigation.The sample was visually inspected at a distance of 12" to 24" under normal conditions of illumination.The technician observed that the catheter was separated; a small section attached to the port and a bigger section is loose.Manufacturing process along with the ifu were reviewed with no findings.Based on the evidence the complaint was confirmed with the most probable root cause is that the damage occurred after the product left the manufacturing facility.
 
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Brand Name
DELTEC PORT-A-CATH II POWER P.A.C
Type of Device
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS,INTRAVASCULAR, PRODUCT CODE: LJT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8701025
MDR Text Key148061556
Report Number3012307300-2019-03604
Device Sequence Number1
Product Code LJT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 08/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/26/2023
Device Catalogue Number21-4455-24 
Device Lot Number3603228
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2019
Date Manufacturer Received07/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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