MAUDE Adverse Event Report: ST PAUL DELTEC PORT-A-CATH LOW PROFILE IMPLANTABLE VENOU; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS,

Catalog Number 21-4071-24

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/28/2020

Event Type  malfunction  

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 photo was received for evaluation.Visual testing was performed.Visual inspection found incorrect additional labeling for china only information was applied (all original labeling was still in place).The root cause of the reported issue was found to be manufacturing.The chinese receiving personnel have been informed of this isolated incident (retraining) and will be aware to look for any future similar incidences.D5- operator of device unknown this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that there are two sets of devices that do not match the model marked on the outer packaging.No patient injury was reported.

• Brand Name: DELTEC PORT-A-CATH LOW PROFILE IMPLANTABLE VENOU
• Type of Device: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS,
• 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: 15334475
• MDR Text Key: 305538168
• Report Number: 3012307300-2022-17198
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K942024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2022

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
• Device Expiration Date: 10/18/2021
• Device Catalogue Number: 21-4071-24
• Device Lot Number: 3341517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1