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

Lot Number UNKNOWN

Device Problem Protective Measures Problem (3015)

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

Event Type  malfunction  

Event Description

It was reported that the needle was protruding from both sides of the disc.The reported issue did not occur while in use with a patient.No patient injury was reported.

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 and functional testing were performed.Visual inspection under normal conditions of illumination found that the needle was not received inside the retractor, it was received inserted in the site covered by the cannula still and the presence of the adhesive was detected in bottom side of the needle, but it is bent.Functional testing could not be performed because the retractor was not provided to perform a thorough investigation.The most probable root cause of the reported issue was found to be that the sample was damaged after it left shm facility, due to the fact the sample complete was not received compete to perform a more thorough investigation and evidence provided shows needle was damaged but adhesive presence was found.Also, this defect is detectable by the inspection per production and quality personnel.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: CADD CLEO INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15360368
• MDR Text Key: 299270302
• Report Number: 3012307300-2022-17806
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female