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

Model Number	21-4455-24
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter scuffed at tip and not conically shaped as usual.Normally, the end to be implanted is conically ground/shaped.The catheter was not implanted and a new port from a different lot was applied.No injury.
Additional Manufacturer Narrative
This 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.A product sample was received for evaluation.Visual and functional testing were performed.The returned sample was received inside of a plastic bag without its original packaging.Two catheters were included in the sample returned.It was observed that the tip was not totally chamfered, for one of the catheters and the rest of the components and assemblies no damages nor workmanship defects were detected.The root cause of the reported issue was found to be the most probable root cause of failure mode reported was defined per operation was not correctly performed since catheter tip is partially chamfered, catheter was not rotated during tip forming.Actions were taken to mitigate the reported issue: an awareness notification was issued to production personnel in order to explain the importance to adherence or following in the procedure.

• Brand Name: DELTEC PORT-A-CATH II POWER P.A.C.
• Common Device Name: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRA
• 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; minneapolis, MN 55442
• MDR Report Key: 14186760
• Report Number: 3012307300-2022-06787
• Device Sequence Number: 5795235
• Product Code: LJT
• UDI-Device Identifier: 10610586032707
• UDI-Public: 10610586032707
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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: 4139527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2021
• 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 Sex: Unknown