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

Catalog Number L-70

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: b3: month and year of event have been provided, day is unknown.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 Description

It was reported that during use, the patient connector broke and blood leaked out.Adverse patient effects are unknown.

Manufacturer Narrative

Two photos received for evaluation.Picture one (1) shows the product.Picture two (2) shows a close-up of the proximal end female luer connector which is observed to have a crack.One (1) unit was received without original package, in used condition.Visual inspection revealed a crack in the female luer connector.The unit failed the leak test.The reported failure mode is confirmed.No root cause determine due complaint is not attributable to the manufacturing process.A notification was sent to the supplier to inform them about the broken luer.The product's history records were reviewed and there were no non-conformances that would have resulted in the reported complaint.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 HOTLINE LOW FLOW DISPSABLE WARMING SET
• Type of Device: 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: 17905996
• MDR Text Key: 325300597
• Report Number: 3012307300-2023-09585
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 30695085407007
• UDI-Public: 30695085407007
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L-70
• Device Lot Number: 4343390
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/26/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1