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

Model Number 21-4477-24

Device Problem Flushing Problem (1252)

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

Event Date 01/26/2021

Event Type  malfunction  

Event Description

It was reported that, upon priming, the nurse noticed there was some resistance when flushing the port; just before connecting to catheter, the nurse could not aspirate or flush through the port septum.Several attempts were made but no success.A new product tray was opened and used.No patient injury was reported.

Manufacturer Narrative

No product was returned; thus the failure mode reported could not be investigated and a root cause could not be determined.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: DELTEC VALVED PEEL AWAY SHEATH INTRODUCER
• Type of Device: PORT CATHETER IMPLANTED SUBCUTANEOUS INTRAVAS
• 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: 15397448
• MDR Text Key: 305803393
• Report Number: 3012307300-2022-18471
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586039997
• UDI-Public: 10610586039997
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 21-4477-24
• Device Catalogue Number: 21-4477-24
• Device Lot Number: 4012723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1