MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CLINT PHARMACEUTICAL CONDUCTION KIT; ANESTHESIA CONDUCTION KIT

Catalog Number	ACL11CH
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 they have been experiencing issues with the needle that was provided in the clint trays.The needle was coring the rubber stoppers and contaminating the syringe/vials.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Corrected: health effect - impact code, there was no patient involvement.No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CLINT PHARMACEUTICAL CONDUCTION KIT
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no.4; tijuana NH ; MX
• Manufacturer Contact: reed covert ; 10 bowman drive; keene, NH 03431 ; 2247062300
• MDR Report Key: 20417441
• Report Number: 1217052-2024-00132
• Device Sequence Number: 8295631
• Product Code: CAZ
• UDI-Device Identifier: 20351688081282
• UDI-Public: (01)20351688081282(17)260815(10)6011840
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K965017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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 Expiration Date: 08/15/2026
• Device Catalogue Number: ACL11CH
• Device Lot Number: 6011840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown