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

Model Number 21-4475-24

Device Problem Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event 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.

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 b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: DELTEC POWER PORT-A-CATH, CATH II, AND P.A.S. POR
• Type of Device: PORT, CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASC
• 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: 15337065
• MDR Text Key: 305589629
• Report Number: 3012307300-2022-17308
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586039973
• UDI-Public: 10610586039973
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1