MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD MEDICATION CASSETTE RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	7300
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that hair was found inside the cassette pouch.Four pictures are attached.There was no patient involvement, and no harm reported.
Additional Manufacturer Narrative
D9: device received on 7/11/2025.H3: the device was received for evaluation.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.Visual, functional and accuracy tests were performed, which confirmed that hair was observed within the cassette.The probable cause was due to a gowning error in tijuana.No further action was taken.

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22286135
• Report Number: 3012307300-2025-07273
• Device Sequence Number: 18375258
• Product Code: FPA
• UDI-Device Identifier: 10610586032394
• UDI-Public: (01)10610586032394(17)290506(10)6005567
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K081156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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 Model Number: 7300
• Device Catalogue Number: 21-7310-24
• Device Lot Number: 6005567
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown