MAUDE Adverse Event Report: CAREFUSION GP TEMPERATURE PROBE, PEDIATRIC; THERMOMETER, ELECTRONIC, CLINICAL

Model Number M1024251

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/29/2014

Event Type  No Answer Provided  

Event Description

We have received a new complaint from (b)(6) about the breakage of the tip part of the temperature probe.According to the report of the customer, the tip part of the probe remained inside the body of the patient.They couldn¿t confirm that was excreted from the body.

Manufacturer Narrative

(b)(4).A request has been made to the customer for return of the complaint device and additional information regarding the incident.Once received, an investigation will be performed.A follow up mdr will be submitted if an investigation is completed.

• Brand Name: GP TEMPERATURE PROBE, PEDIATRIC
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills 60061
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4136715
• MDR Text Key: 4926852
• Report Number: 1423507-2014-00022
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: M1024251
• Device Lot Number: 13G73116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1