MAUDE Adverse Event Report: ST PAUL DELTEC; PORT A CATH

Model Number	21-4009-24
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical implantable ports|deltec port-a-cath port placed for chemo patient on (b)(6).Then reported catheter broke and leaked into the right atrium.Intervention was necessary through catheterization and it was extracted through the femoral artery.
Additional Manufacturer Narrative
This remediation 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.Visual and functional tests were performed.The customer provided eight (8) pictures for review/evaluation: the pictures provided were reviewed and confirmed by visual observation that the catheter is broken, therefore it is concluded the confirmation reported.One unit was received for evaluation; the unit was returned decontaminated inside a plastic bag which was not its original package.The complainant returned unit was visually inspected at 12 in to 16 in under normal conditions of illumination.It was observed that the catheter was cut.The complaint was confirmed.It is likely that the product became damaged after it left the manufacturing site.The root cause was undetermined.Actions taken: incoming inspection pulled the component from ship to stock and will start monitoring with a sampling single to inspect by attribute in each received lot.A notification to production personnel about failure mode reported was conducted by quality engineer in order to create awareness about failure reported.

• Brand Name: DELTEC
• Common Device Name: PORT A CATH
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11957289
• Report Number: 3012307300-2021-05708
• Device Sequence Number: 1295469
• Product Code: LJT
• UDI-Device Identifier: 10610586023750
• UDI-Public: 10610586023750
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K830730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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: 01/27/2023
• Device Model Number: 21-4009-24
• Device Catalogue Number: 21-4009-24
• Device Lot Number: 88X053
• 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: 05/07/2021
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2018
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Hispanic