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

Model Number	L-10
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the use of the product, leakage of fluid from it was observed.No patient injury reported.
Additional Manufacturer Narrative
Device serial number/lot number is unknown, no product information has been provided to date.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
Other, other text: h6: health impact and evaluation codes: updated.H10: no lot number was provided; therefore, device history record review could not be performed.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found no damage except for contamination.Functional testing found a leak is observed in the valve disc.The root cause of the reported issue was found to be lack of adhesive during bonding assembly.An awareness notification was conducted by the quality engineer on (b)(6) 2023 to the production personnel to explain the importance of adherence in the procedure.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).

• 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; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 15735375
• Report Number: 3012307300-2022-26766
• Device Sequence Number: 15009042
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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 Model Number: L-10
• Device Catalogue Number: L-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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