MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD HIGH VOLUME ADMINISTRATION SET WITH FLOWSTOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7346-24

Device Problem Product Quality Problem (1506)

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

Event Date 05/29/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: no product was returned; therefore, the reported complaint could not be confirmed and the root cause could not be determined.If the product is returned, this complaint will be reopened for further investigation.No problems or issues were identified during this device history record (dhr) review.

Event Description

It was reported that the patient's tubing was defective and the pump was very slow and not draining the entire bag.However, the pump was tested and the pump was not defective and that it drained the bag with no problems.The patient have had some defective tubing lately and was curious if this could also be the case.No patient injury reported.

• Brand Name: CADD HIGH VOLUME ADMINISTRATION SET WITH FLOWSTOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17174905
• MDR Text Key: 317596949
• Report Number: 3012307300-2023-06481
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161953
• UDI-Public: 15019517161953
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• 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: 4291448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1