MAUDE Adverse Event Report: ST PAUL CADD EXTENSION SET WITH MICROBORE TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7106-24

Device Problems Device Alarm System (1012); Pressure Problem (3012)

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

Event Date 10/14/2021

Event Type  malfunction  

Event Description

Information was received indicating that during use of this smiths medical cadd extension sets, the pump exhibited "constantly pressure alarm".No patient injury reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4) no problem or issues were identified during the device history record review.A sample was received for evaluation.Sample was received in used conditions without its original packaging.In the pictured it was observed that the filter was occluded; the failure mode reported is confirmed.During functional testing the sample was tested using a syringe with colored water to detect any occlusion.During the test, the water did not pass-through filter.The complaint is confirmed.Continue with the analysis, we tried to replicate the failure mode.Based on the tests results, it is concluded that the failure could be reproduced in two ways: 1.When the excess of solvent is not cleaned before to assembly the tube with the component.2.When the tube is introduced two times in the solvent dispenser (procedure is not followed).An alert was generated to ensure adherence to manufacturing procedure related to clean the excess of solvent before to assemble tube with the component.Also, personnel notification was performed to notify production personnel about the failure mode reported by the customer.

• Brand Name: CADD EXTENSION SET WITH MICROBORE TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12789575
• MDR Text Key: 280756604
• Report Number: 3012307300-2021-10979
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: 10610586023279
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

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: 21-7106-24
• Device Catalogue Number: 21-7106-24
• Device Lot Number: 4098657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 10/15/2021
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1