MAUDE Adverse Event Report: ST PAUL DELTEC POWER PORT-A-CATH II PORTS; PORT AND CATHETER, IMPLANTED,SUBCUTANEOUS, INTRAVA

Model Number 21-4455-24

Device Problem Leak/Splash (1354)

Patient Problems Distress (2329); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that there was device leakage.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Other text: b5: additional event information received.H6: event problem and evaluation codes: updated.

Event Description

Additional information received on 25-oct-2022 via email and attached to complaint object: event occurred: 07jul2022.Two trained and experienced nurses used the product when the fault occurred.Patient demographics provided; updated relevant test, pre-existing condition information, patient harm information (no lasting physical damage but the distress and discomfort caused by the required medical intervention should not be disregarded), medical intervention, patient outcome: resolved.

Manufacturer Narrative

Other text: there were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record review.No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.

• Brand Name: DELTEC POWER PORT-A-CATH II PORTS
• Type of Device: PORT AND CATHETER, IMPLANTED,SUBCUTANEOUS, INTRAVA
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; se-103 33; minneapolis, MN 55442
• MDR Report Key: 15521066
• MDR Text Key: 302277203
• Report Number: 3012307300-2022-20572
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2022

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 Operator: Health Professional
• Device Model Number: 21-4455-24
• Device Catalogue Number: 21-4455-24
• Device Lot Number: 4108594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 10/25/2022; 11/28/2022
• Supplement Dates FDA Received: 11/04/2022; 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 109 KG