MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD SYNAPSYS¿

Catalog Number 444150

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/04/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Initial reporter address: (b)(6).

Event Description

It was reported that bd synapsys¿ locked accessions, are preventing from seeing cultures.The following information was provided by the initial reporter: the customer has about 250 locked accessions and about half were locked more than 24 hours ago.This is preventing the customer from viewing the cultures in mwc and plates in rfr.We have tried restarting services, restarting workstations, restarting iis, restarting sql and the synapsys servers, but the plates stay locked for an extended period of time.Screenshots and examples are attached in the case.Hazard, injury or erroneous results? no; hazard, injury or erroneous results details.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2022-01474 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.

Event Description

It was reported that bd synapsys¿ locked accessions, are preventing from seeing cultures.The following information was provided by the initial reporter: the customer has about 250 locked accessions and about half were locked more than 24 hours ago.This is preventing the customer from viewing the cultures in mwc and plates in rfr.We have tried restarting services, restarting workstations, restarting iis, restarting sql and the synapsys servers, but the plates stay locked for an extended period of time.Screenshots and examples are attached in the case.Hazard, injury or erroneous results? no.Hazard, injury or erroneous results details.

• Brand Name: BD SYNAPSYS¿
• Type of Device: NA
• 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: 15992067
• MDR Text Key: 306902246
• Report Number: 1119779-2022-01474
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: BA
• PMA/PMN Number: NA
• 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: 03/03/2023

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 Catalogue Number: 444150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2018
• 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