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

Model Number 21-7394-24

Device Problems Product Quality Problem (1506); Improper Flow or Infusion (2954)

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

Event Type  malfunction  

Event Description

It was reported the disposable didn't deliver the medication.No patient injury was reported.

Manufacturer Narrative

Other text: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Device evaluation: the sample returned, it consists in one (1) unit the returned sample was received inside of a plastic bag without its original packaging.Visual inspection: the complaint returned unit was visually inspected at a distance of 12? to 16? under normal conditions of illumination according to the procedure ?visual inspection?.Results: no damages or other defects were detected on the sample.Is observed that the blue clip is not present.Functional testing: the sample was set for accuracy testing using a pump.Results: sample failed.Delivery accuracy rate was (b)(6) (out of spec).(average delivery error acceptable is (b)(6) (see attachment for disposable accuracy test report)) thus, the failure mode reported is confirmed.Pump tube arch height: the sample was tested to measure the height of the pump tube arch and determine if is under or out of spec following the procedure ?work instruction for tube arch height inspection.?.Results: the sample passed the arch height tube measure; green color is an ?ok? tube arch is under spec, red color is an ?ng? tube arch is out of spec.Mitigations are on place in manufacturing process for delivery accuracy issue: production personnel performs pump tube assembly after 100% visual verification of the arc height using a vision system, to confirm is within the acceptance range, before to move to the next operation.The operator proceeds with the adhesive to place it on the pump tube across to the pressure plate and not moved.These two operations conducted to assembly the pump arch tube, confirms that if is well bonded the tube shall not be out of specification, because is already stick on the pressure plate, and eliminate the occurrence of presence of delivery accuracy error caused due to the pump arch tube out of specification.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CADD ADMINISTRATION SETS 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: 16811334
• MDR Text Key: 313964303
• Report Number: 3012307300-2023-04518
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: 10610586027536
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7394-24
• Device Catalogue Number: 21-7394-24
• Device Lot Number: 4279967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1