MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD BACTEC FX, INSTRUMENT TOP, PACKAGED; BLOOD CULTURE

Model Number 441385

Device Problem Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that during a service repair of the bd bactec¿ fx, instrument top, packaged the feet were raised to move the instrument forward, and the instrument started to tip.A technician was hit by the machine, but was not seriously injured by the falling instrument.

Event Description

It was reported that during a service repair of the bd bactec¿ fx, instrument top, packaged the feet were raised to move the instrument forward, and the instrument started to tip.A technician was hit by the machine, but was not seriously injured by the falling instrument.

Manufacturer Narrative

H.6.Investigation summary.Complaint for a bd bactec fx top instrument (p/n 441385, s/n ft3340) falling over and hitting a laboratory technician was reported.The incident occurred while a bd field service engineer (fse) was resolving a temperature sensor fault under wo-01585350 for pr# 1779842.During this work order, the instrument's feet were raised to move the instrument so the fse could get behind the instrument.Once the instrument was moved, the instrument's feet were not lowered back to the ground.The fse proceeded to open drawer a half way and drawer b about a quarter.The instrument started to tip over when the fse went to get a screwdriver.As the instrument was falling, it hit a laboratory technician.The laboratory technician was not seriously injured.Bd quality did not receive any returned instrument or parts for investigation.Review of the device history record is not necessary due to the age of the instrument.Service history review for s/n ft3340 revealed no previous complaints for injuries or instruments falling over.This complaint is an unconfirmed failure of bd product, as the instrument's feet were not lowered back to the ground after moving the instrument.When servicing an instrument, the bd bactec fx service training guide states that all four instrument feet should remain on a flat surface when the instrument is moved or the weight is shifted to prevent the instrument from tipping over.No new trends, risks, or hazards were identified as a result of the complaint.Bd quality will continue to closely monitor for trends associated with this issue.

• Brand Name: BD BACTEC FX, INSTRUMENT TOP, PACKAGED
• Type of Device: BLOOD CULTURE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 10553798
• MDR Text Key: 208292907
• Report Number: 1119779-2020-00338
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904413859
• UDI-Public: 00382904413859
• Combination Product (y/n): N
• PMA/PMN Number: K915796A
• 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: 10/13/2020

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 Model Number: 441385
• Device Catalogue Number: 441385
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 08/27/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other