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

Model Number 21-7220-24

Device Problem Protective Measures Problem (3015)

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

Event Type  malfunction  

Manufacturer Narrative

No product sample was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review could not be performed as the catalog number and lot number were unknown.No root cause could be determined as the complaint could not be confirmed.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 needle did not retract when inserting device into abdomen.No patient injury was reported.

• 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: 15362145
• MDR Text Key: 305160549
• Report Number: 3012307300-2022-17899
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586028339
• UDI-Public: 30610586028339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7220-24
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 3677257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1