MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE ACCESSORIES; WARMER, THERMAL, INFUSION FLUID

Model Number	L-10
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
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 during the pre-use check, the connector broke off.No patient injury or clinical affects was reported.No additional information is available for this complaint.
Additional Manufacturer Narrative
Device evaluation: two photographs were submitted along with the returned device.Picture one shows a hotline gas vent outside of its original packaging, the packaging, and a stopcock valve; the male luer connector is observed to be broken and the broken part of the connector is attached to the stopcock valve.Picture two shows a close-up of the damage to broken male luer connector in the gas vent, the damage shows signs of excessive force applied.One (1) device was received with its original packaging, in used condition, and decontaminated.Along with the unit a stopcock valve was received.Upon visual inspection the male luer connector on the gas vent was observed to be broken with additional damage observed around the connector exit.The broken piece of the male luer connector was attached to the stopcock valve.Three impact tests were performed and were unable to reproduce the failure reported.The root cause was attributed to the male luer becoming damaged after it left the manufacturer facility.A device history record (dhr) reviewed showed no reported discrepancies during the manufacturing of the reported lot number.No corrective actions taken however the failure will be monitored to determine if new actions need to be taken.

• Brand Name: LEVEL 1 HOTLINE ACCESSORIES
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16585278
• Report Number: 3012307300-2023-02804
• Device Sequence Number: 1635572
• Product Code: LGZ
• UDI-Device Identifier: 40695085401002
• UDI-Public: 40695085401002
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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: 04/11/2026
• Device Model Number: L-10
• Device Catalogue Number: L-10
• Device Lot Number: 4273788
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 04/02/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• 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