MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BACTEC 9240 SYSTEM

Model Number BACTEC 9240 SYSTEM

Device Problem Component Falling (1105)

Patient Problems Swelling (2091); Injury (2348)

Event Date 11/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the cover strip on the door of a bactec 9240 system fell onto the collar bone of the technician resulting in swelling and a small open wound.Medical intervention required.

Manufacturer Narrative

Investigation summary: (b)(4) complaint was due to an injury received by the customer as a result of loose cover strips not firmly secured to the instrument.The customer was injured when the lab technician opened the door, the cover strip on the side fell out and hit her shoulder.The lab technician¿s collarbone was bruised and she had a minor laceration.The customer was treated for a laceration at a hospital and released to go back to work.Customer injury due to mechanical force is captured in baltrmbactecinstraph ver a rev 7 line 8.2 hazard: mechanical force, adverse affect (harm): user injured (serious injury), sev: s4, potential causes of hazard: collapse of supporting surface, existing risk control measure: pre-installation checklist.Trending for safety complaints for this instrument is defaulted at an alert level of 2 and an action level of 3 ((b)(6) 2017-(b)(6) 2017).Instrument/mechanical complaints for this instrument are at an alert level of 8 and action level of 10 ((b)(6) 2017- (b)(6) 2017).22 instrument/mechanical complaints were reported between (b)(6) 2017 and (b)(6) 2017.4 instrument/mechanical complaints were reported for november.(b)(4) is the only complaint reporting customer injury due to a mechanical issue during this period and for the month of (b)(6) 2017.No corrective action is required at this time.Based on the serial# of the instrument, this instrument was manufactured in 2004.The potential cause of this hazard may have been due to the customer having more than one instrument stacked on top of one another or a single instrument at an elevated level placed above the operator's shoulder.The operator may have been injured when operating the instrument from a higher proximity.The operators were aware that the cover strips were loose per information from the customer.

• Brand Name: BACTEC 9240 SYSTEM
• Type of Device: BACTEC 9240 SYSTEM
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 7089569
• MDR Text Key: 94067458
• Report Number: 1119779-2017-00010
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: BACTEC 9240 SYSTEM
• Device Catalogue Number: 445475
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention