MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SETS - NON FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7094-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported the disposable tubing was leaking at the filter while in use.Patient using blincyto continuous infusion.The same problem occurred last week with tubing from the same lot number.Additional information: patient is monitored by a local nurse via an external service provider.The bag (with tubing) is inserted continuously over a period of 3 or 4 days.The patient had to return earlier to clinic to change her equipment.No clinical consequences for the moment as the equipment has been changed the 2 times there was a leak.The patient is taking other medications, unrelated to the present incident: xanax, imovane, dexeryl, pantoprazole, macrogol, contramal, wellvone, zelitrex: all these treatments are per the clinic suggestion.
Additional Manufacturer Narrative
One sample was received for evaluation.Visual inspection revealed the product in used conditions; conditions without its original packaging, decontaminated and inside in a plastic bag; no damage was detected.Functional testing was performed, and the reported issue was replicated; complaint was confirmed.The root cause was determined to be due to usage of a solution by the end user that contained high levels of surfactants.However, it was not possible to determine why type of solution was used during the hospital procedure.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No action was taken.D3, g1, g2 email address: regulatory.Responses@icumed.Com.

• Brand Name: CADD ADMINISTRATION SETS - NON FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17599389
• Report Number: 3012307300-2023-08260
• Device Sequence Number: 18034929
• Product Code: FPA
• UDI-Device Identifier: 10610586025266
• UDI-Public: 10610586025266
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K933390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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 Catalogue Number: 21-7094-24
• Device Lot Number: 4295924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/28/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 57 KG