MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. DELTEC; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 21-4055-24

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

Surgeon could flush the port fine , but it did not pull back blood, only bubbles.Malfunctioned.We opened another "port only" box to replace it.Manufacturer response for port-a-cath, port-a-cath 11 (per site reporter).Reported the event details to smiths medical (now icu medical) customer service.

• Brand Name: DELTEC
• Type of Device: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 13590838
• MDR Text Key: 286061520
• Report Number: 13590838
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2022

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 Model Number: 21-4055-24
• Device Catalogue Number: 21-4055-24
• Device Lot Number: 4227827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1