MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE DISPOSABLE ADMINISTRATION SETS; 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 05/01/2022

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, the infusion line was found damaged.No additional information was available.No patient was involved.

Manufacturer Narrative

Device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Pictures received: two pictures were included in agile attachments for evaluation, cracked luer was detected.Samples received: two (2) samples were received in used conditions without original package.Visual inspection results: a crack was observed on luer lock adapter female.Based on the sample provided, analysis conducted on physically evaluation, trend analysis for this failure mode in complaints, root cause can be determined as supplier item fault.Supplier was notified about the issue reported for broken component.The cause of the reported problem was traced to a component supplied to the manufacturing process.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.

• Brand Name: LEVEL 1 HOTLINE DISPOSABLE ADMINISTRATION SETS
• 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; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 14798298
• MDR Text Key: 301911702
• Report Number: 3012307300-2022-12431
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• 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: 4218637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1