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

Model Number 21-7349-24

Device Problem Failure to Deliver (2338)

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

Event Type  malfunction  

Manufacturer Narrative

Initial reporter also sent report to fda?: unknown.No product has been returned.A device history record (dhr) review cannot be performed as no lot or serial numbers were provided.If the product is returned, this complaint will be reopened for further investigation.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the device did not deliver the medication.No patient injury was reported.

Manufacturer Narrative

Additional information received by smiths medical/icu on 10-jun-2022 via email and attached to complaint object: the alleged concern did not happen in our institution as mentioned before - therefore there is no information we have.

• Brand Name: CADD ADMINISTRATION SETS WITH AIR ELIMINATING FILT
• 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; minneapolis, MN 55442
• MDR Report Key: 14575048
• MDR Text Key: 293297625
• Report Number: 3012307300-2022-10473
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517184235
• UDI-Public: 15019517184235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7349-24
• Device Catalogue Number: 21-7349-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1