MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CARTRIDGE CAP CADD MS3 3ML; SET, I.V. FLUID TRANSFER

Catalog Number 67229424

Device Problem Break (1069)

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

Event Date 01/26/2023

Event Type  Injury  

Event Description

Patient reports cartridge cap broke yesterday.Replacement being sent with order.Nothing wrong with either pump.No serial number available for cartridge caps.Patient being sent replacement cap.No side effect or missed dose reported.Unknown if defective capp on hand if needed for return.No other information available.Used to infuse remodulin at above rate & frequency.No additional information available.Reported to (b)(6) by: patient/caregiver.

• Brand Name: CARTRIDGE CAP CADD MS3 3ML
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16306014
• MDR Text Key: 308973413
• Report Number: MW5114716
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 67229424
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female