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

Catalog Number L-70

Device Problems Break (1069); Material Separation (1562)

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

Event Date 08/22/2023

Event Type  malfunction  

Event Description

It was reported that upon connecting the device to the equipment it was noticed the "port" was damaged making the device unusable.There was no patient involvement.

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.

Manufacturer Narrative

Device evaluated by manufacturer and h6.Evaluation codes: email is: (b)(6) two (2) units were received without their original packaging, in used condition, and decontaminated.Per visual inspection, the proximal end female luer connectors were observed to be broken at the tip.Although both units arrived with the threads of the luer connectors damaged, the functionality of the returned units was able to be tested by a leak test.Both units failed the leak test.The complaint was confirmed.After reviewing the mitigations that are performed during the manufacturing process to detect damaged component, the root cause is that the connectors became damaged after the product left the manufacturing facilities as this damaged would be detected during manufacturing process.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.This failure will continue to be monitored.

• Brand Name: LEVEL 1 LOW FLOW HOTLINE DISPOSABLE 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: 17761104
• MDR Text Key: 323636941
• Report Number: 3012307300-2023-08944
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 30695085407007
• UDI-Public: 30695085407007
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• 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: 4253641
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/01/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1