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

Model Number	L-70
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: b3: month and year of event have been provided, day is unknown.D4: udi section, lot number, expiration date, and h4: manufacture date are unknown, no 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.
Event or Problem Description
It was reported that while in use with a patient, a leak occurred due to damage to the main body connection.Adverse effects are unknown.
Additional Manufacturer Narrative
Other text: d4: udi updated.H6: evaluation codes updated device evaluation: one sample was received for evaluation.A visual inspection found the sample in used condition without original packaging.A crack was found in the female luer connector.During the functional testing, the unit failed the leak test.The reported failure mode is confirmed.Based on the replication of the failure mode results, the crack reported is not attributable to the manufacturing process.No root cause determined due to the complaint not being attributable to the manufacturing process.A notification was sent to the supplier regarding the issue found.

• 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: 17863467
• Report Number: 3012307300-2023-09518
• Device Sequence Number: 14934887
• Product Code: LGZ
• UDI-Device Identifier: 30695085407502
• UDI-Public: 30695085407502
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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 Model Number: L-70
• Device Catalogue Number: L-70NI
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/13/2023
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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