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

Model Number 441385

Device Problems Break (1069); Misassembly by Users (3133)

Patient Problems Headache (1880); Pain (1994)

Event Date 07/12/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd bactec¿ fx, instrument top, packaged drawer handle was broken and the customer placed tape on the handle to hold it in place.A lab employee pulled on the handle and the tape failed.The employee fell to the ground and hit their head.The employee sought medical attention, and indicated they had a headache and bruised neck.The customer missed a day of work under a workman¿s comp claim.

Event Description

It was reported that the bd bactec¿ fx, instrument top, packaged drawer handle was broken and the customer placed tape on the handle to hold it in place.A lab employee pulled on the handle and the tape failed.The employee fell to the ground and hit their head.The employee sought medical attention, and indicated they had a headache and bruised neck.The customer missed a day of work under a workman¿s comp claim.

Manufacturer Narrative

H6: investigation summary: customer reported drawer handle broken issue on a bd bactec fx top instrument (p/n 441385, s/n (b)(6).Customer indicated that the drawer handle was broken 2 weeks ago, and they used tape to hold the drawer handle together.An employee yanked on handle and fell on the ground, hit the head.Employee went to hospital and checked out, missed one day of work under workman¿s comp.Injury caused headache and neck bruising.A bd filed service engineer was dispatched and replaced the handle of drawer a under contract.Review of the device history record is not necessarily due to the age of the instrument.Service history review for s/n ft0564 revealed no previous complaints related to this failure.Bd quality did not receive any parts for investigation.This complaint is a confirmed failure of bd product.The root cause is broken drawer handle.Bd quality will continue to closely monitor for trends associated with this failure.H3 other text : see h.10.

• Brand Name: BD BACTEC FX, INSTRUMENT TOP, PACKAGED
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 10365012
• MDR Text Key: 202018504
• Report Number: 1119779-2020-00255
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 07/12/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention