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
Event or Problem Description
It was reported that, with a patient on the table, the surgeon attempted to use the port but the introducer was too large to fit into the lock on the port.Two (2) trays were attempted.No patient injury was reported.
Additional Manufacturer Narrative
The samples were returned and visually inspected at a distance of 12 in to 16 in under normal conditions of illumination.The catheter received is bigger than required.One (1) video was received which showed: the two shelf box where the product was extracted; the catheter from each box would not fit inside an introducer; the catheter was bigger than the introducer; attempt to connect the catheter to the port and it was not possible to fit the catheter between the sleeve and the tube.The reported problem was confirmed and it can be concluded that the most likely root cause was during the packaging process (pick and place) of the catheter.The device history record (dhr) review indicated that there were no deviations or issues that 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).

• 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: 15397526
• Report Number: 3012307300-2022-18483
• Device Sequence Number: 5057238
• 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: Health Professional
• 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: 05/05/2020
• 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