Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS MEDICAL ASD, INC. PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 21-4055-24
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code Rupture (2208)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
Information was received indicating that 10-20 days following implant of a smiths medical port-a-cath®ii implantable access systems the skin is reported to rupture causing the chamber to come out.Subsequently, the patient was brought to surgery for intervention which was reported to delay chemotherapy treatment.No further adverse effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEMS
Common Device Name
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7350679
Report Number3012307300-2018-00635
Device Sequence Number10778631
Product Code LJT
UDI-Device Identifier10610586023552
UDI-Public10610586023552
Combination Product (Y/N)N
Initial Reporter CountryGR
PMA/510(K) Number
K962695
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Physician
Device Expiration Date10/19/2021
Device Catalogue Number21-4055-24
Device Lot Number3349908
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/09/2018
Initial Report FDA Received Date03/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
-
-