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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the water was leaking because the "line was damaged".No patient involvement reported.
Additional Manufacturer Narrative
Other, 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
One (1) video and four (4) photos were provided by the customer which were used to conduct the device analysis since the physical unit, by the time this investigation is being documented, has not been received.Based on the pictures received it could be observed that the female luer connector has a crack along the luer, the reported failure mode is confirmed.This defect may have been due to mishandling of the product.Replication of the failure mode ? retest in leak tester: to replicate the failure mode a device was taken to retest in leak test in order to create damage in the female luer, leak test was performed 3 times in the device.Results: during the third attempt the female luer presented damage in the connection part, however, it was not similar to the sample reported.No root cause determine due complaint is not attributable to the manufacturing process.Production personnel performs 100% visual inspection to components on the assembly during operation, hotline fluid supply assembly, to verify that there are no damaged components in the assembly that could cause faulty functionality.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.For all enquiries or follow-up questions related to the record, do not use (b)(6) located in sections g.1., please direct those to the following: (b)(6).

• 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: 18231982
• Report Number: 3012307300-2023-10821
• Device Sequence Number: 3306125
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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
• Device Lot Number: 4346352
• Was Device Available for Evaluation?: No
• 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: 02/29/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• 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