MAUDE Adverse Event Report: ST PAUL DELTEC; PORT AND CATHETER

Model Number	3921848
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the connector is small and the catheter can not enter.
Additional Manufacturer Narrative
A sample was returned for evaluation.The complainant's returned unit was visually inspected.The port was assembled with an incorrect component which was smaller in size.Potential root causes were: during kitting of clearance sleeves, mislabeling occurred, and the operator did not detect the discrepancy or during returns both part number of the sleeves were mixed.A quality alert was issued.Awareness notification was disseminated to personnel in order to explain the importance to adherence or following in the procedure.A new visual aid was created for personnel to inspect sleeves before assembly on 21-sep-2022.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: DELTEC
• Common Device Name: PORT AND CATHETER
• 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; rm401, (gems bldg, gunja-dong); minneapolis, MN 55442
• MDR Report Key: 13417768
• Report Number: 3012307300-2022-02308
• Device Sequence Number: 3963235
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 11/24/2024
• Device Model Number: 3921848
• Device Catalogue Number: 21-4475-24
• Device Lot Number: 3921848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/07/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• 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