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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. IMPLANTABLE ACCESS SYSTEM; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. DELTEC® PORT-A-CATH®II POWER P.A.C. IMPLANTABLE ACCESS SYSTEM; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 21-4455-24
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code Pain (1994)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
See mfr: 3012307300-2018-00280; 3012307300-2018-00281; 3012307300-2018-00282; 3012307300-2018-00283.Lot number provided by customer is not a valid lot number.
 
Event or Problem Description
It was reported that the explanting doctor noticed holes in the catheter of a deltec® port-a-cath®ii power p.A.C.Implantable access system.Issues with the catheter had to be explanted when one patient complained of pain.There was no patient injury associated with this occurrence.
 
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Brand Name
DELTEC® PORT-A-CATH®II POWER P.A.C. IMPLANTABLE ACCESS SYSTEM
Common Device Name
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
1265 gray fox road
st. paul MN 55112
MDR Report Key7278788
Report Number3012307300-2018-00279
Device Sequence Number14015406
Product Code LJT
UDI-Device Identifier10610586032707
UDI-Public10610586032707
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K072657
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/16/2018
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 Health Professional
Device Catalogue Number21-4455-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/09/2018
Initial Report FDA Received Date02/16/2018
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 Required Intervention;
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