MAUDE Adverse Event Report: ST PAUL CADD CASSETTE RESERVOIRS WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7302-24

Device Problems Leak/Splash (1354); Product Quality Problem (1506)

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

Event Date 04/20/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported the disposable leaked.No patient injury was reported.No adverse patient effects were reported by the customer".

Manufacturer Narrative

Other text: d10.Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One (1) unit of part number 21-7302-24 and one (1) unit of part number 21-7047-24 were received with their original packaging and in unused condition.Two (2) units of part number 21-7047-24 were received without their original packaging, in used condition, and decontaminated.Additionally, a bard miniloc, two (2) equashield luer locks, and a clave connector were received in their original packaging and in unused condition.No damage or dysfunctional conditions were observed on any of the components during visual inspection.No leaks were detected on any of the units during functional testing.The complaint was not confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No corrective actions were taken because the mitigations on place were revised and are being executed as determined by procedure.This failure will continue to be monitored to determine if new actions need to be taken.

• Brand Name: CADD CASSETTE RESERVOIRS WITH FLOW STOP
• Type of Device: 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: 16856476
• MDR Text Key: 314455567
• Report Number: 3012307300-2023-04940
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

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
• Device Operator: Health Professional
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4354562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 08/20/2023
• Supplement Dates FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1