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

Model Number 21-4477-24

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2020

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 304635706
• Report Number: 3012307300-2022-18495
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586039997
• UDI-Public: 10610586039997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1