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

Model Number	21-4455-24
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that leakage was detected between markings 55 and 60 cm of the catheter and a joint was noted to have several holes.No patient injury was reported.
Additional 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 sample was received for evaluation.Visual and functional testing were performed.The unused sample was opened and no damage or workmanship defects were detected on the catheter; however, a small tear was found on the used catheter between the section 50 and 60.After a review of the different verifications that are performed during the manufacturing process to detect damaged components, it is most probable that the reported damage occurred after the product left the facility.Production personnel were notified by quality engineer, as an awareness, of the defect reported by the user.The root cause of this failure was unable to be determined.This remediation mdr was generated under protocol (b)(4).As a result of warning letter cms# (b)(4).

• Brand Name: DELTEC PORT-A-CATH II POWER P.A.C.
• Common Device Name: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVAS
• 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: 15326752
• Report Number: 3012307300-2022-16936
• Device Sequence Number: 15074204
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

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: 01/07/2024
• Device Model Number: 21-4455-24
• Device Catalogue Number: 21-4455-24
• Device Lot Number: 3756963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown