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) ports were received for evaluation.Samples were visually inspected at a distance of 12" to 16" under normal conditions of illumination.The catheter received is bigger than required; the failure mode was confirmed.It can be concluded that the most likely root cause is during the packaging process (pick and place) of the catheter, the line clarence process was not properly followed.A nonconformance report (ncr) was released in order to evaluate the investigation and determine the correction action required.A device history record (dhr) review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.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 catheter 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: 15443222
• Report Number: 3012307300-2022-19557
• Device Sequence Number: 5595258
• 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
• Type of Report: Initial
• Report Date (Section B): 09/17/2022

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: 05/15/2020
• 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: 09/17/2022
• 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