MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® GENERAL PURPOSE PROBES; THERMOMETER, ELECTRONIC, CLINICAL

Device Problem Break (1069)

Patient Problems Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)

Event Date 10/16/2017

Event Type  Injury  

Event Description

Information was received indicating that this nasopharyngeal temperature probe broke and the end piece became lodged in the patient's right nare.The anesthesiologist attempted to remove the end piece, however it slipped further down.An ear, nose, and throat (ent) physician was called in and they were successfully able to remove the piece.There was a minimal amount of bleeding following the removal.No additional adverse patient effects were reported.

• Brand Name: LEVEL 1® GENERAL PURPOSE PROBES
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; a d no.4; parque industrial internaciona; tijuana, bc ; MX
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7042778
• MDR Text Key: 92456136
• Report Number: 3012307300-2017-02426
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 83