MAUDE Adverse Event Report: NULL CADD CASSETTE RESERVOIRS - NON FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7002-24

Device Problem Leak/Splash (1354)

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

Event Date 03/29/2023

Event Type  malfunction  

Manufacturer Narrative

No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.No lot number was provided; therefore, a device history record (dhr) review could not be conducted.If the device becomes available, smiths medical will re-open the complaint file and submit a supplemental mdr as necessary in accordance with 21 cfr 803.56.

Event Description

It was reported the disposable was leaking.Patient not affected.No patient injury.No additional information available.

Event Description

Lot number has been updated from unknown to 4271467 after review on 09-aug-2023 of the complaint notification.

Manufacturer Narrative

Other, other text: b5, d4, h4.Updated - lot number and item number were found.G5.510k number is unknown.

• Brand Name: CADD CASSETTE RESERVOIRS - NON FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 16761344
• MDR Text Key: 313498492
• Report Number: 3012307300-2023-04242
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

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: Health Professional
• Device Catalogue Number: 21-7002-24
• Device Lot Number: 4271467
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1