MAUDE Adverse Event Report: BECTON DICKINSON TURBO TEMP ORAL PROBE LONG; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2887B

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that turbo temp oral probe long was defective.This occurred on 7 occasions.The following information was provided by the initial reporter: material no: 2887b batch no: 890001255893, unknown- provided lot would not populate.It was reported that there are defective springs.The probe sticks are unable to push the button.

Manufacturer Narrative

Correction: general dissatisfaction of the product does not impact the intended use of the device, which does not lead to serious injury to the clinician or patient.This complaint is not mdr reportable.

Event Description

It was reported that turbo temp oral probe long was defective.This occurred on 7 occasions.The following information was provided by the initial reporter: material no: 2887b batch no: 890001255893, unknown- provided lot would not populate it was reported that there are defective springs.The probe sticks are unable to push the button.

• Brand Name: TURBO TEMP ORAL PROBE LONG
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11092708
• MDR Text Key: 224396237
• Report Number: 2243072-2020-02184
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1