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

Model Number 21-7346-24

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/14/2021

Event Type  malfunction  

Event Description

Information was received indicating that during use of this smiths medical cadd administration sets, chemotherapy leaking at the filter site of the tubing was noticed.No patient injury reported.

Manufacturer Narrative

This mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.Pictures were submitted per picture 1, it can be seen 1 sample without leaks.Per picture 2, it can be seen the same sample with a leak in the filter, however it is not possible to determine where the leak come from per picture provided.The root cause of the reported issue was found to be unknown.Actions were taken to mitigate the reported issue: no actions were taken.

• Brand Name: CADD ADMINISTRATION SETS
• 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: 12624137
• MDR Text Key: 276351513
• Report Number: 3012307300-2021-09919
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161953
• UDI-Public: 15019517161953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• 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: 4143032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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