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

Model Number	21-4475-24
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the user pulled the catheter to combine it into the connector, the catheter slid out.No patient injury was reported.
Additional Manufacturer Narrative
A product sample was received for evaluation.A device history record (dhr) review was conducted using similar lots which indicated all inspections were completed and no issues were noted during manufacture.A review of the manufacturing process for a similar lot was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.Visual and functional testing were performed.No discrepancies were detected upon visual inspection and assembly of the unused samples received.Functional tests were performed on the sample to verify the catheter could detach easily.No discrepancies were found, the catheter kept on the port after pulling it.No discrepancies were found.Root cause cannot be determined since the complaint was not confirmed due to the fact the sample was successfully tested and no discrepancies were detected on visual inspection.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: DELTEC POWER PORT-A-CATH, CATH II, AND P.A.S. PORT
• Common Device Name: PORT, CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVA
• 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: 15336128
• Report Number: 3012307300-2022-17268
• Device Sequence Number: 6438727
• Product Code: LJT
• UDI-Device Identifier: 10610586039973
• UDI-Public: 10610586039973
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 09/01/2022

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 Model Number: 21-4475-24
• Device Catalogue Number: 21-4475-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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