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

Lot Number 3868856

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 07/22/2020

Event Type  malfunction  

Event Description

During the case a smiths medical deltec port-a-cath 2 low profile polysulfone/titanium venous access system polyflow polyurethane catheter, 1.9mm (5.8fr) o.D.X 1.0mm i.D., 6 fr introducer mediport was being placed.Ref:(b)(4), lot:3868856, exp:08/29/2024, manufacture date 09/04/2019, gtin (b)(4).The access sheath that pulls apart did not completely separate at the bottom and the surgeon was forced to cut it apart.The device malfunctioned.The part that malfunctioned is a disposable part.

• Brand Name: DELTEC PORT-A-CATH
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10337661
• MDR Text Key: 200799486
• Report Number: 10337661
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/27/2020

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 Lot Number: 3868856
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2020
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA