MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMIN SETS; DEVICE, WARMING, BLOOD AND PLASMA

Model Number L-70

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Month is known, actual date is unknown.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 during the pre-use check, the connection part of the bag was found broken.No patient involvement.

Manufacturer Narrative

Other text: h6 evaluation codes: updated h10 device evaluation: one device and two photographs were submitted for evaluation.Photo one shows a the warming set next to its original packaging.The complete device is observed, but no damage or dysfunctional conditions are observed.Photo two shows the label of the reported lot and part numbers.Visual inspection of the returned device showed the proximal end female luer connector is observed to be cracked.Based on the sample returned by the customer it was not possible to replicate the issue or confirmed as manufacturing process issue.After reviewing the mitigations that are performed during the manufacturing process to detect damage component, the most probable root cause is that the broken luer connector damage occurred after the product left the manufacturing facility.A review of the device history record (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No corrective actions are required because the mitigations in place were revised and are executing as is determined by procedure.This failure will continue to be monitored to determine if new actions need to be taken.

• Brand Name: LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMIN SETS
• Type of Device: DEVICE, WARMING, BLOOD AND PLASMA
• 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: 16585441
• MDR Text Key: 311747704
• Report Number: 3012307300-2023-02811
• 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: BK860023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• 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: 4326084
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/14/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1