MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING

Model Number 442020

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

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

Event Date 08/04/2022

Event Type  malfunction  

Event Description

It was reported by the customer that bd bactec¿ peds plus¿/ f culture vials (plastic) flagged a false positive.There was one occurrence in this event with no patient impact.The following information was provided by the customer: machine flagged for false positive.

Manufacturer Narrative

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 by the customer that bd bactec¿ peds plus¿/ f culture vials (plastic) flagged a false positive.There was one occurrence in this event with no patient impact.The following information was provided by the customer: "machine flagged for false positive.".

Manufacturer Narrative

After additional review, this mfr# 1119779-2022-01168 should be considered canceled.This is not a reportable event.All positive vials must be gram-stained and subcultured to confirm true positivity prior to reporting.

• Brand Name: BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)
• 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: 15358924
• MDR Text Key: 302112434
• Report Number: 1119779-2022-01168
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420208
• UDI-Public: 00382904420208
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K151866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 442020
• Device Catalogue Number: 442020
• Device Lot Number: 2013114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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