MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC 9120, REMANUFACTURED; SYSTEM, BLOOD CULTURING

Model Number	445702
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported while using bd bactec¿ 9120, remanufactured false positive results were obtained in rack c and d.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: the client has been claiming that rack c and d have been presenting some cases of false positives, to solve this problem we carry out calibrations of all racks as well as restoring factory defaults according to the manufacturer's manual procedure,.
Additional Manufacturer Narrative
Investigation summary: a false positive issue was reported on a bd bactec 9000 instrument (p/n 445702, s/n ub4292).The client had been claiming that rack c and d had had been presenting some cases of false positives, to solve this issue they carried out calibrations of all racks as well as restoring factory defaults according to the manufacturer¿s manual procedure, after they released the equipment for use.Review of the device history record is not required due to the age of the instrument.Service history record review revealed no previous complaints for this issue.Bd quality did not receive any returned parts or instrument for investigation.This complaint is an unconfirmed failure of a bd product.The root cause is unable to be determined.No new trends, risks, or hazards were identified as a result of the complaint.Bd quality will continue to closely monitor for trends associated with this failure.H3 other text : see h10.
Event or Problem Description
It was reported while using bd bactec¿ 9120, remanufactured false positive results were obtained in rack c and d.There was no report of patient impact.The following information was provided by the initial reporter, translated from portuguese to english: the client has been claiming that rack c and d have been presenting some cases of false positives, to solve this problem we carry out calibrations of all racks as well as restoring factory defaults according to the manufacturer's manual procedure,.

• Brand Name: BD BACTEC 9120, REMANUFACTURED
• Common Device Name: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11696069
• Report Number: 1119779-2021-00680
• Device Sequence Number: 19712988
• Product Code: MDB
• UDI-Device Identifier: 00382904457020
• UDI-Public: 00382904457020
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K922475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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
• Operator of Device: Other
• Device Model Number: 445702
• Device Catalogue Number: 445702
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1