MAUDE Adverse Event Report: OAKDALE LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION SET; WARMER, THERMAL, INFUSION FLUID

Model Number	L-70
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that saline was not circulated after injection.The liquid stops at the middle of the line.No medical intervention or patient injury.
Additional Manufacturer Narrative
H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.One (1) unit was received without its original packaging label, in used condition, and decontaminated inside a ziplock bag.Two (2) photos were included for evaluation; picture one shows the label with the part number, lot number and expiration date.Picture two shows the unit.Per visual inspection, there was no evidence of delamination, damage or any discrepancies that could cause the failure mode reported.The unit passed the leak test.The complaint was not confirmed.No root cause performed since the complaint was not confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No action taken since the complaint was not confirmed.

• Brand Name: LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION SET
• 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: 18231980
• Report Number: 3012307300-2023-10822
• Device Sequence Number: 3306124
• Product Code: LGZ
• UDI-Device Identifier: 30695085407502
• UDI-Public: 30695085407502
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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: 12/02/2025
• Device Model Number: L-70
• Device Catalogue Number: L-70NI
• Device Lot Number: 4218652
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/23/2023
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2021
• 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