MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L GENERAL PURPOSE PROBE 12FR SOFT, 400 SERIES; THERMOMETER, ELECTRONIC, CLINICAL

Model Number	81-02S412
Medical Device Problem Codes	No Device Output (1435); Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Temperature sensor that has been installed on patient (b)(6) ((b)(6)), did not perform reading.
Additional Manufacturer Narrative
A user facility complaint was received on 11/11/2022 reporting, "temperature sensor that has been installed on patient (b)(6) ((b)(6)), did not perform reading.".The sample has been requested for return but has not been returned to deroyal for evaluation at this time.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once more.
Additional Manufacturer Narrative
The device was not available for return to deroyal for evaluation.A device history record (dhr) and work orders involved were reviewed and it was confirmed that no issues were reported with the regular manufacturing process and all work orders were within the specifications set.The failure modes and effects analysis (fmea) and material review report (mrr) were reviewed as well and it was confirmed that both were up to date and verified.A complaint review of the past two years was conducted showing that of the 46450 units of part number 81-02s412 sold, only one complaint was received.An inventory check of the of the probes were made by deroyal, a total of 125 were inspected and no discrepancies were identified.Root cause: because the sample was unavailable for return or inspection, no issues were able to be identified from the investigation and therefore no root cause can be determined.No corrective actions will be taken at this time, but deroyal will continue to monitor for trends around this product.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: GENERAL PURPOSE PROBE 12FR SOFT, 400 SERIES
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway,; la aurora, heredia 146 ; CS 146
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway,; la aurora, heredia 146 ; CS 146
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19928478
• Report Number: 9613793-2022-00001
• Device Sequence Number: 2847403
• Product Code: FLL
• UDI-Device Identifier: 00749756812573
• UDI-Public: 00749756812573
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K200631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2022

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 Model Number: 81-02S412
• Device Lot Number: 55661471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown