MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 TRAUMA FAST FLOW DISPOSABLE; DEVICE, WARMING, BLOOD AND PLASMA

Model Number	D-100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a leak was noticed at the y site on the spiking set to the bag.No patient injury was reported.The outcome was resolved by using another set of tubing and it was spiked with no leakage.
Additional Manufacturer Narrative
Other text: 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
D10.Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received in use condition, decontaminated, without its original packaging and inside a plastic bag.Each joint was visually inspected, and no visual defects were detected that would cause leakage in the "y" connection.Water was introduced in the product for functional testing and a leak was observed in the "y" connection.The complaint was confirmed.The root cause for the leak condition was due to lack of adhesive between "y" connection.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.Awareness was made to operation personnel and the issue will be monitored for threshold or escalation.

• Brand Name: LEVEL 1 TRAUMA FAST FLOW DISPOSABLE
• Common Device Name: DEVICE, WARMING, BLOOD AND PLASMA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17227517
• Report Number: 3012307300-2023-06872
• Device Sequence Number: 7177685
• Product Code: KZL
• UDI-Device Identifier: 40695085410004
• UDI-Public: 40695085410004
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: BK860023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

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: 08/06/2020
• Device Model Number: D-100
• Device Catalogue Number: D-100
• Device Lot Number: 4025979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown