MAUDE Adverse Event Report: BECTON DICKINSON BD ALARIS® TURBO TEMP ORAL PROBE; THERMOMETER, ELECTRONIC, CLINICAL

Catalog Number 2887B

Device Problem Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2023

Event Type  malfunction  

Event Description

It was reported that the bd alaris® turbo temp oral probe produced an error code and would not acquire/save the test during use.The following information was provided by the initial reporter: "error code temp 306 on iqvitals unit - oobf.Cannot acquire/save test.Is there any adverse events/serious injury reported? no.".

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that the bd alaris® turbo temp oral probe produced an error code and would not acquire/save the test during use.The following information was provided by the initial reporter: "error code temp 306 on iqvitals unit - oobf.Cannot acquire/save test.Is there any adverse events/serious injury reported? no.".

Manufacturer Narrative

Investigation summary it was reported by the customer that there is error code temp 306 on iqvitals unit - oobf.Were reviewed the possible problems that a turbo temp oral prob long could have.According to the 145836 spec,dfu,eng,218x dir 10000002188 rev.00.Could be the follow: oral monito mode rectal fix me cal broken probe return to base both probes out low battery repalce these problems could appear in the thermometer display, of a ivac turbo temp (electronic thermometer), however, according to the customer confirmation, he used a midmark digital vital signs device.Nevertheless, no further investigation could be performed since no samples were available for evaluation.Root cause definition root cause was not defined since customer did not provide a lot number or a sample for evaluation.

• Brand Name: BD ALARIS® TURBO TEMP ORAL PROBE
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16865875
• MDR Text Key: 314527806
• Report Number: 2243072-2023-00733
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

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 Operator: Other
• Device Catalogue Number: 2887B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/03/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/23/2023
• 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: Initial
• Patient Sequence Number: 1