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

Catalog Number	21-7336-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was in use for infusion with home care patient.The reporter stated the administration kit "broke" during infusion of antibiotic.The reporter stated the patient's caregiver stopped the infusion, applied a clamp to the set and applied a cap to the patient's central venous catheter.The reporter stated the patient reported to hospital to get a replacement administration set and continue the infusion.No adverse effects to patient reported.
Additional Manufacturer Narrative
H3: one sample of the cadd administration set from p/n (b)(6)l/n unknown was received in used condition inside a plastic bag without its original packaging.The sample was visually inspected at a distance of 12" to 16" under normal conditions of illumination.The sample was received with the tube 12" cut and without the filter, but the coiled tube came with a filter port bonded.A review of the production floor was conducted, a sample of 32 units were taken in order to verify that all joins are properly adhered and there no damage on the filters; no discrepancies were detected.The reported issue was confirmed.The most probable cause of the issue was that the filter was damaged after it left production.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• MDR Report Key: 9101883
• Report Number: 3012307300-2019-05153
• Device Sequence Number: 3007678
• Product Code: FPA
• UDI-Device Identifier: 10610586027291
• UDI-Public: 10610586027291
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2020

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: Lay User/Patient
• Device Catalogue Number: 21-7336-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 10/15/2019; 12/07/2019
• Initial Report FDA Received Date: 09/22/2019
• Supplement Report FDA Received Date: 11/11/2019; 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1