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

Model Number 445870

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 10/26/2021

Event Type  malfunction  

Event Description

It was reported that the bd bactec¿ mgit¿ 960 system experienced a broken tube that resulted in sample leakage.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: reported that the tube in drawer c station n20 went (b)(6).When she went to remove the tube she found the tube empty with a crack in it.The sample had leaked out and dried up within the station.

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.

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 the bd bactec¿ mgit¿ 960 system experienced a broken tube that resulted in sample leakage.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: reported that the tube in drawer c station n20 went positive.When she went to remove the tube she found the tube empty with a crack in it.The sample had leaked out and dried up within the station.

Event Description

It was reported that the bd bactec¿ mgit¿ 960 system experienced a broken tube that resulted in sample leakage.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: reported that the tube in drawer c station n20 went positive.When she went to remove the tube she found the tube empty with a crack in it.The sample had leaked out and dried up within the station.

Manufacturer Narrative

Investigation summary: a failure was reported on a mgit 960 instrument (p/n 445870, s/n (b)(6).Customer had indicated about the broken bottle drawer c.Bd field service engineer (fse) was dispatched and discovered the spill in smm.The fse replaced the smm (pn# 44589509 - mgit meas module repaired).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.Device was installed on 1/24/2002.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 was spill in the smm.Bd quality will continue to closely monitor for trends associated with this complain.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12902496
• MDR Text Key: 286066389
• Report Number: 1119779-2021-01896
• 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: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• 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: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1