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

Catalog Number 445570

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

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2021

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that while testing with bd bactec¿ 9120 blood culture system a false positive result was obtained.It is unknown what type of confirmation testing was performed.There was no report of patient impact.

Event Description

It was reported that while testing with bd bactec¿ 9120 blood culture system a false positive result was obtained.It is unknown what type of confirmation testing was performed.There was no report of patient impact.

Manufacturer Narrative

H6: investigation: a failure was reported on a bd bactec 9120 instrument (p/n 445570, s/n, s/n (b)(6)).Customer indicated false positives.No erroneous results were reported to doctors, and patients were not impacted.A bd remote assistance communicated with the customer to follow up on the event and learned that there was no reoccurrence of false positives after preventative maintenance took place.This is an unconfirmed failure of a bd product.Bd quality did not receive any returned materials for review.Review of device history record for ub1689 is not needed due to the age of the instrument.Service history for ub1689 was reviewed and revealed no previous complaint related to false positives.The root cause was 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 complaint.

• Brand Name: BD BACTEC 9120 BLOOD CULTURE SYSTEM
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11382152
• MDR Text Key: 242951871
• Report Number: 1119779-2021-00395
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• PMA/PMN Number: K922475
• 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: 07/23/2021

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
• Device Operator: Other
• Device Catalogue Number: 445570
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1