MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. PORT-A-CATH II; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 21-4465-24

Device Problems Crack (1135); Infusion or Flow Problem (2964); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 03/24/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a low profile i port was inserted on patient (b)(6) at (b)(6) in (b)(6).The i port was attempted to be used for patient's first chemo treatment, but was unable to flush the port.Pt was rescheduled for a port exchange on (b)(6) 2022.M.D.Surgically removed i port and found a cut on the port tube, after trying to flush the tube.Rep from (b)(6) was notified and a report was made with them.The port was then picked up by rep to send back for evaluation.Fda safety report id # (b)(4).

• Brand Name: PORT-A-CATH II
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.
• MDR Report Key: 14788211
• MDR Text Key: 294678471
• Report Number: MW5110464
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-4465-24
• Device Lot Number: 3801076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White