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

Model Number	21-4477-24
Medical Device Problem Code	Flushing Problem (1252)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2022-18471
• Device Sequence Number: 5183639
• Product Code: LJT
• UDI-Device Identifier: 10610586039997
• UDI-Public: 10610586039997
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• 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: 08/16/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• 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