MAUDE Adverse Event Report: CAREFUSION, INC PROBE, REUSABLE GEN PURPOSE TEMP, ADULT; THERMOMETER PROBE, ELECTRONIC, CLINICAL

Model Number M1024247

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint device was returned to the manufacturing site for evaluation.A follow up report will be submitted once the evaluation has been completed.(b)(4).

Event Description

During use there was loss of tip of probe.It was possible that the top of probe was lost in intestinum rectum of the patient.Next day, the patient received x-ray examination but the tip of probe was not found.

Manufacturer Narrative

(b)(4).The compliant device was returned and evaluated by the manufacturing site.A visual examination of the returned device showed that the thermistor position had signs of significant stretching over the thermistor.Per the instructions for use (ifu), the cleaning stroke of the cable surface must be performed away from the sensing tip toward the connector end.Failure to follow these instructions can cause the material to stretch and cause the tip to break off when force is applied.The root cause for this defect was determined to be the customer¿s failure to follow the cleaning procedure outlined in the ifu.(b)(4).

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.(x-ray was required), investigation completion date.

• Brand Name: PROBE, REUSABLE GEN PURPOSE TEMP, ADULT
• Type of Device: THERMOMETER PROBE, ELECTRONIC, CLINICAL
• Manufacturer (Section D): CAREFUSION, INC; kuortaneenkatu 2; helsinki 00510 ; FI 00510
• Manufacturer (Section G): CAREFUSION, INC; kuortaneenkatu 2; helsinki ; FI
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887 ; 8473628056
• MDR Report Key: 5607988
• MDR Text Key: 44455092
• Report Number: 3010838917-2016-00014
• 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: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M1024247
• Device Catalogue Number: M1024247
• Device Lot Number: 15J93932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other