MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7346-24

Device Problem Output Problem (3005)

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

Event Date 07/09/2022

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.No information has been provided to date.

Event Description

It was reported that the tubing was set to prime but it wouldn't prime properly.The fluid was moving through very slowly and kept shooting back like there was a blockage downstream.The user could not find any kinks, no clamps were closed.The user loosened the cap on the end of the tube but was unable to resolve the problem.After priming the line of 30 milliliters of fluid, the user noticed that the fluid had only traveled about halfway through the tubing.The user proceeded to change the tubing set and was able to prime properly.No patient injury was reported.

Manufacturer Narrative

H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.The sample returned: consists of one (1) unit, the returned sample was received in a plastic bag which is not the original packaging.Visual inspection results: no obstructions nor other workmanship defects were detected in none of the joins of the product.Functional test results: no discrepancies were detected, sample was fully priming and connected without difficulty, the pump was set running, liquid flow through the whole device without interruptions, no alarms were activated, thus, the failure mode reported is not confirmed.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.

Manufacturer Narrative

While performing a review of the complaint, it was discovered that the file was inadvertently assessed as reportable.The malfunction will not likely to cause or contribute to death or serious injury and no patient death, serious injury, and there is no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.This complaint file is no longer considered reportable, please disregard any reports associated with it.Bcain.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 14th floor, north tower; minneapolis, MN 55442
• MDR Report Key: 15164269
• MDR Text Key: 304623637
• Report Number: 3012307300-2022-14665
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161953
• UDI-Public: 15019517161953
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031361
• 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,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7346-24
• Device Catalogue Number: 21-7346-24
• Device Lot Number: 4248681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1