MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORT-A-CATH® IMPLANTABLE VENOUS ACCESS SYSTEMS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 21-4055-24

Device Problems Difficult to Remove (1528); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event 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.

• Brand Name: PORT-A-CATH® IMPLANTABLE VENOUS ACCESS SYSTEMS
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 1265 grey fox rd; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 6969903
• MDR Text Key: 89993131
• Report Number: 3012307300-2017-02298
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586023552
• UDI-Public: 10610586023552
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K962695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 10/15/2021
• Device Catalogue Number: 21-4055-24
• Device Lot Number: 3323411
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention