MAUDE Adverse Event Report: ST PAUL DELTEC VALVED PEEL-AWAY SHEATH INTRODUCER; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCU

Model Number	21-4477-24
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Three (3) unused samples were received inside a plastic bag without their original sealed packaging.The samples were visually inspected at a distance of 12 in to 16 in under normal conditions of illumination.The catheter received was bigger than required; the failure mode was confirmed.It can be concluded that the most likely root cause was during the packaging process (pick and place) of the catheter and that the line clearance process was not properly followed up by procedure.Corrective and preventive measures were implemented.The device history record (dhr) was reviewed and no deviations or issues were encountered related with the event reported.The lot was manufactured in compliance with the specifications of the device.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the device received was a 6 fr port (that requires a 6 fr catheter to attach to the port); however, the catheter in the package was size 8 fr which was too big to attach to the port.No patient injury was reported.

• Brand Name: DELTEC VALVED PEEL-AWAY SHEATH INTRODUCER
• Common Device Name: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCU
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15397568
• Report Number: 3012307300-2022-18495
• Device Sequence Number: 20359090
• Product Code: LJT
• UDI-Device Identifier: 10610586039997
• UDI-Public: 10610586039997
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2024
• Device Model Number: 21-4477-24
• Device Catalogue Number: 21-4477-24
• Device Lot Number: 3921849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 09/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown