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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORT-A-CATH® IMPLANTABLE VENOUS ACCESS SYSTEMS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. PORT-A-CATH® IMPLANTABLE VENOUS ACCESS SYSTEMS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 21-4055-24
Medical Device Problem Codes Difficult to Remove (1528); Retraction Problem (1536)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/28/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported that the smiths medical port-a-cath® implantable venous access systems guide-wire could not be pulled out of the vein after puncture was complete.Ultrasound was used to confirm correct puncture site but it was required that the nurse change out the smiths medical device.No adverse patient effects were reported.
 
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Brand Name
PORT-A-CATH® IMPLANTABLE VENOUS 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 Key6969903
Report Number3012307300-2017-02298
Device Sequence Number13469601
Product Code LJT
UDI-Device Identifier10610586023552
UDI-Public10610586023552
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K962695
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source consumer,foreign,health profe
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/23/2017
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 Nurse
Device Expiration Date10/15/2021
Device Catalogue Number21-4055-24
Device Lot Number3323411
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/10/2017
Initial Report FDA Received Date10/23/2017
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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