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

Model Number 21-7359-24

Device Problem Material Integrity Problem (2978)

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

Event Date 09/13/2022

Event Type  malfunction  

Event Description

It was reported that the device had a loose component which should be fixed to the extension.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

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

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual inspection found damage under the pump tube was detected.No other analysis was performed.The root cause of the reported issue was found to be manufacturing - uv automatic dispense system incorrectly setup.The following actions were taken: pm-297 was updated on 30-sep-2016 to added the specification range drop size for bond pump tube to housing operation and added adhesive application instructions to clarify the procedure.Visual aid was created and referenced on pm-297 on 06-jun-2017 to provided visual acceptance criteria for bonding of the pump tube to housing.Pm-297 was updated on 24-nov-2017 to added certified personnel as requirement for inspection of the bond pump tube to housing operation this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the fixed part of the extension is loose, impairing the administration of the medication, which ended up not being infused.Another manipulation was performed, with no adverse reaction to the patient.

• 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; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15521017
• MDR Text Key: 302346506
• Report Number: 3012307300-2022-20635
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027406
• UDI-Public: 10610586027406
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7359-24
• Device Catalogue Number: 21-7359-24
• Device Lot Number: 4136416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1