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

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; attempted 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 b10009406, as a result of warning letter cms# (b)(4).

Event 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.

• 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: 15397451
• MDR Text Key: 305804448
• Report Number: 3012307300-2022-18473
• 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: Health Professional
• 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: 09/09/2022
• 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: 05/05/2020
• 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
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White