MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE DISPOSABLES; WARMER, THERMAL, INFUSION FLUID

Model Number L-70

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

A product sample was received and is awaiting evaluation and 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 before opening the package, the customer noticed the connector was damage (or broken).No patient injury reported.

Manufacturer Narrative

H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual inspection found cracking on luer lock adapter female, this cosmetic issue could cause leakage or another functional fail test, failure mode is confirmed.The root cause of the reported issue was found to be supplier item fault.Scar submitted to supplier for luer connector this was submitted to supplier on 27-nov-2020, in which supplier was notified about the issue reported for broken component, lot number reported showed that pieces were built with luer connector with lot number raw material 0004081226 with manufacturing date on april 2019, so based on manufacturing date, this action can be assigned to this complaint.Reported lot (raw material) was manufactured before the corrective actions above.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: LEVEL 1 HOTLINE DISPOSABLES
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15951995
• MDR Text Key: 308037023
• Report Number: 3012307300-2022-27806
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 20695085407000
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

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
• Device Operator: Health Professional
• Device Model Number: L-70
• Device Catalogue Number: L-70
• Device Lot Number: 4290655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 01/16/2023
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1