MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ MGIT¿ 960 SYSTEM; SYSTEM, BLOOD CULTURING

Model Number 445870

Device Problem Break (1069)

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

Event Date 01/21/2022

Event Type  malfunction  

Event Description

It was reported that a tube broke in the bd (b)(6) system a drawer, contaminating it with the leaked patient sample.There was no report of adverse user or patient impact.The following information was provided by the initial reporter: "the customer has noticed a broken mgit tube in the (b)(4) instrument in the a drawer." "broken mgit tube and spill.The a drawer and the instrument are potentially contaminated at this time.".

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.

Event Description

It was reported that a tube broke in the bd bactec¿ mgit¿ 960 system a drawer, contaminating it with the leaked patient sample.There was no report of adverse user or patient impact.The following information was provided by the initial reporter: "the customer has noticed a broken mgit tube in the m50 instrument in the a drawer." "broken mgit tube and spill.The a drawer and the instrument are potentially contaminated at this time.".

Manufacturer Narrative

H.6.Investigation: a failure was reported on a mgit 960 instrument (p/n 445870, s/n (b)(6)).Customer indicated about the issues with closing the drawers.A field service engineer (fse) was dispatched and installed (pn# 445895 - sample measurement module mgit 1 ), (pn# 440054 - set of slides drawer mgit 960 spare).The instrument deemed functional and handed over to the customer for use.This is a confirmed failure of a bd product.Review of device history record for this instrument not required for this complaint.The complaint was evaluated via other elements of the investigation.The results of this evaluation have not identified any new hazards, new risks, or specific trends.Service history review was performed for this instrument and no additional work orders were observed for the complaint failure mode reported.Samples were not received by quality for investigation.If samples are received at a later date, the complaint may be reopened.The root cause faulty drawer slides.Bd quality will continue to closely monitor for trends associated with this complaint.

• Brand Name: BD BACTEC¿ MGIT¿ 960 SYSTEM
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13524210
• MDR Text Key: 285634767
• Report Number: 1119779-2022-00231
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904458706
• UDI-Public: 00382904458706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 445870
• Device Catalogue Number: 445870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1