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

Model Number	21-7336-24
Medical Device Problem Codes	Material Separation (1562); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter occupation: pharmacy supervisor, oncology.
Event or Problem Description
Information was received that a smiths medical cadd administration set was infusing blinatumomab for a patient for approximately four hours when the set broke.The patient has been receiving this infusion for several months and noted they did not get the set "stuck on anything".No adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information received by smiths medical that there was a patient present but no clinical injury.Reported that the patient had to return to clinic to have a new bag made which resolved the issue.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9227283
• Report Number: 3012307300-2019-04397
• Device Sequence Number: 2409243
• Product Code: FPA
• UDI-Device Identifier: 10610586027291
• UDI-Public: 10610586027291
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2023
• Device Model Number: 21-7336-24
• Device Catalogue Number: 21-7336-24
• Device Lot Number: 3674591
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CADD INFUSION PUMP