MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD ADMINISTRATION SET- NON FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7095-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the cadd administration set leaked.The kit was use to administer 133.8 ug pouch of blincyto with the solis vip 2120 cadd pump for a 96-hour home delivery.After more or less than 42 hours of the connection, the patient noticed that there was a leak in the 0.22 um filter.The infusion had to be prepared again due to the amount of medication that was leaked.There was no reported injury to the patient.
Additional Manufacturer Narrative
Evaluation results: one cadd administration set was returned for investigation.The sample was visually inspected at a distance of 12 to 16 inches under normal conditions of illumination.A delamination was found in at least one join of the filter within the tube.A leak was observed fleeing from the air vent of the filter.A root cause for the product problem was not established.
Additional Manufacturer Narrative
Additional information was received indicating the date of the event: (b)(6) 2019.

• Brand Name: CADD ADMINISTRATION SET- NON FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8946518
• Report Number: 3012307300-2019-04466
• Device Sequence Number: 2099797
• Product Code: FPA
• UDI-Device Identifier: 10610586025273
• UDI-Public: 10610586025273
• Combination Product (Y/N): N
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2019

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: Other
• Device Catalogue Number: 21-7095-24
• Device Lot Number: 3600548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 10/08/2019; 11/10/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 11/07/2019; 12/10/2019
• 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 SOLIS VIP 2120