MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. 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 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found the returned sample was received inside a plastic bag with the original open packaging.The sample presents deformation in the tube.A review of the manufacturing process was conducted.The training records of the operators of the line were reviewed; no discrepancies were found.Process review was conducted by document control technician in order to verify there are no situations or practices that could create the event.There is no risk of this kind of damage in the process.Three samples were produced were tested and the tubes returned to the original form without damage or deformations.Production performs 100 percent visual inspection to components and assembly in order to verify that there is no deformed or damaged components in the assembly that could cause a bad functionality of the device.Quality takes a sample in order to perform a visual inspection to verify components do not presents voids, dents, holes and cracks; the sample is based on the expected daily output.The root cause of the issue could not be determined.

Event Description

It was reported immediately after opening the package, the customer noticed the tube was partially deformed.No patient injury reported.

• Brand Name: LEVEL 1 HOTLINE DISPOSABLES
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15665520
• MDR Text Key: 306996031
• Report Number: 3012307300-2022-26102
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• 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: 3732132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1