MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMIN SETS; DEVICE, WARMING, BLOOD AND PLASMA

Model Number	DI-60HL
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the chemical solution leaked when using the product.The event occurred during priming.There was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3: month and year of event have been provided; day is unknown.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.
Additional Manufacturer Narrative
H3 and h6 - evaluation codes: updated.Device evaluation: one unit was returned for investigation.Visual inspection found no damage or other defects were detected on the sample.During the functional test, a leak was found in the union with s-10 solvent check valve umbrella to the tubing.Leaking was confirmed.Root cause was not established.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No action taken.

• Brand Name: LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMIN SETS
• Common Device Name: DEVICE, WARMING, BLOOD AND PLASMA
• 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: 19087605
• Report Number: 9617604-2024-00309
• Device Sequence Number: 15366602
• Product Code: KZL
• UDI-Device Identifier: 20695085406010
• UDI-Public: (01)20695085406010(17)260704(10)4305708
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: BK860023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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: 07/04/2026
• Device Model Number: DI-60HL
• Device Catalogue Number: DI-60HL---801
• Device Lot Number: 4305708
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• 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