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

Model Number L-70

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

Event Description

It was reported that water was constantly leaking during priming.Checked to confirm that the connection part was broken.No patient involved.Outcome of the event was reported as unknown.No further information was given.

• Brand Name: LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION 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: 18048490
• MDR Text Key: 327082934
• Report Number: 3012307300-2023-10119
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 30695085407502
• UDI-Public: 30695085407502
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L-70
• Device Catalogue Number: L-70NI
• Device Lot Number: 4237176
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1