MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1; WARMER, THERMAL, INFUSION FLUID

Model Number L-70NI

Device Problems Break (1069); Device Damaged Prior to Use (2284)

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

Event Date 03/14/2022

Event Type  malfunction  

Event Description

It was reported that the product arrived damaged, which was discovered upon opening.No patient injury reported.

Manufacturer Narrative

Event problem and evaluation codes: updated.H10: device evaluation: the sample was returned for investigation.The sample was received in used condition without the original package.The sample was visually inspected, and a crack on the luer lock adapter was seen, which could possibly cause a leak.No other analysis was done.Based on the reported issue, arrived damaged- discovered upon opening, the allegation was confirmed, and analysis conducted in this investigation traced the root cause to supplier item fault.For corrective action, a notification of the complaint was submitted to production to be aware of the issue.Reported lot was manufactured before corrective actions were taken.A device history review summary stated that the lot met the requirements to release the lot with no deviations identified during their manufactured.An internal scar has been opened and this issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional corrective actions will be taken.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: LEVEL 1
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16710382
• MDR Text Key: 313018027
• Report Number: 3012307300-2023-03915
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L-70NI
• Device Catalogue Number: L-70NI
• Device Lot Number: 4139857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1