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

Model Number	21-4455-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Distress (2329); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Other text: b5: additional event information received.H6: event problem and evaluation codes: updated.
Event or Problem 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.

• Brand Name: DELTEC POWER PORT-A-CATH II PORTS
• Common Device Name: 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
• Report Number: 3012307300-2022-20572
• Device Sequence Number: 2674531
• Product Code: LJT
• UDI-Device Identifier: 10610586032707
• UDI-Public: 10610586032707
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 10/25/2022; 11/28/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/04/2022; 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 109 KG