MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 SNUGGLE WARM CONVECTIVE BODY BLANKET; SYSTEM, THERMAL REGULATING

Catalog Number	SWU-2003
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.H3: 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 or Problem Description
It was reported that there was a wrong reference label/ wrong component.There was no patient involvement.
Additional Manufacturer Narrative
D9: device returned on 5/8/2025.H3: the device was received for evaluation.No discrepancies or anomalies were observed during the manufacturing of this lot.Visual and functional tests were performed, and 27 inserts out of 36 returned samples were found with incorrect labels.The customer's problem was replicated.Capa-0009735 was issued on 02-jun-2025 to address the issue reported.
Additional Manufacturer Narrative
This supplemental is to provide further explanation regarding the investigation for the labelling complaint: these discrepant inserts present a negligible risk.Serious harm is improbable.The inserts provide general product information only and do not contain information such as indications for use and warnings, which are found in the product instructions for use (ifu).All the affected product boxes contained the correct ifus.Traceability is maintained through all other product labeling, which is also correct.

• Brand Name: LEVEL 1 SNUGGLE WARM CONVECTIVE BODY BLANKET
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel aleman km; apodaca CP666 03; MX CP66603
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21927391
• Report Number: 3012307300-2025-04986
• Device Sequence Number: 9086084
• Product Code: DWJ
• UDI-Device Identifier: 10610586043345
• UDI-Public: (01)10610586043345(17)270806(10)6025327
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: SWU-2003
• Device Lot Number: 6025327
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 06/18/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/09/2025; 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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