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

Model Number 21-4071-24

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2017

Event Type  malfunction  

Event Description

Sheath was too small to pass the catheter.The two defective devices were given to the manufacture representative.

• Brand Name: DELTEC
• Type of Device: PORT &; CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6892919
• MDR Text Key: 87658726
• Report Number: 6892919
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2017,09/15/2017

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: Physician
• Device Model Number: 21-4071-24
• Device Lot Number: 87X050
• Other Device ID Number: TWO OF THE SAME TYPE OF DEVIC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1