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

Model Number	21-4425-24
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Pneumonia (2011)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was injured - extravasation event relating to port-a-cath.Port-a-cath removed, small hole halfway along the length of the portacath line.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problems or issues were identified during this device history record review.No product sample was received; therefore, visual and functional testing could not be performed.No serial number was provided.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: DELTEC PORT-A-CATH POWER P.A.C
• Common Device Name: PORT 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; 494 rosebank road; minneapolis, MN 55442
• MDR Report Key: 14219506
• Report Number: 3012307300-2022-06980
• Device Sequence Number: 17178082
• Product Code: LJT
• UDI-Device Identifier: 10610586032646
• UDI-Public: 10610586032646
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2025
• Device Model Number: 21-4425-24
• Device Catalogue Number: 21-4425-24
• Device Lot Number: 3999309
• 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: 03/30/2022
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown