MAUDE Adverse Event Report: ST PAUL DELTEC PORT-A-CATH II POWER P.A.C.; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVAS

Model Number 21-4455-24

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 01/20/2020

Event Type  malfunction  

Event Description

It was reported that leakage was detected between markings 55 and 60 cm of the catheter and a joint was noted to have several holes.No patient injury was reported.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.The unused sample was opened and no damage or workmanship defects were detected on the catheter; however, a small tear was found on the used catheter between the section 50 and 60.After a review of the different verifications that are performed during the manufacturing process to detect damaged components, it is most probable that the reported damage occurred after the product left the facility.Production personnel were notified by quality engineer, as an awareness, of the defect reported by the user.The root cause of this failure was unable to be determined.This remediation mdr was generated under protocol (b)(4).As a result of warning letter cms# (b)(4).

• Brand Name: DELTEC PORT-A-CATH II POWER P.A.C.
• 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: 15326752
• MDR Text Key: 304719258
• Report Number: 3012307300-2022-16936
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586032707
• UDI-Public: 10610586032707
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2024
• Device Model Number: 21-4455-24
• Device Catalogue Number: 21-4455-24
• Device Lot Number: 3756963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1