MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ AST BROTH; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Model Number 246003

Device Problem Contamination (1120)

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

Event Date 07/02/2022

Event Type  malfunction  

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 that 100 bd phoenix¿ ast broth tubes were contaminated.There was no report of patient impact.The following information was provided by the initial reporter: some tubes are pink colour and some are turbid in the current lot number.

Manufacturer Narrative

The following fields were updated: b5.It was reported that 200 bd phoenix¿ ast broth tubes were contaminated.There was no report of patient impact.The following information was provided by the initial reporter: some tubes are pink colour and some are turbid in the current lot number.D4.Medical device lot #: an additional lot number was reported to have the same issue.Information for the two affected lots is as follows: d4.Medical device lot #: 1363985; d4.Medical device expiration date: 24-dec-2022; h4.Device manufacture date: 29-dec-2021.D4.Medical device lot #: 1342646; d4.Medical device expiration date: 03-dec-2022; h4.Device manufacture date: 08-dec-2021.

Event Description

It was reported that 200 bd phoenix¿ ast broth tubes were contaminated.There was no report of patient impact.The following information was provided by the initial reporter: some tubes are pink colour and some are turbid in the current lot number.

Manufacturer Narrative

H.6 investigation summary: this complaint is confirmed.This complaint is for foreign material in phoenix ast broth (246003) batch numbers 1363985 and 1342646.The customer did provide photos for investigation, however no product returns.The photos illustrated discolored tubes.Based off the photos, this complaint is confirmed.A review of quality notifications revealed two quality notifications generated on the complaint batch, not related to this defect.A review of complaints was performed and revealed one additional complaint on the complaint batch, not related to this defect.Complaint trending was performed and no trends were identified associated with this defect.A bd id/ast plant quality will continue to monitor for trends associated with this defect.Per baltrmphxidastaph rev 10 version h, id 15.0, a defective product obvious to user has a severity assessment of s1.Per baltms0184 ver k a complaint with a severity ranking of s1 or s2 may require investigational testing, including retain sample analysis.However, the customer returned photos which were used for the investigation; therefore, a review of retention samples is not required.

Event Description

It was reported that 100 bd phoenix¿ ast broth tubes were contaminated.There was no report of patient impact.The following information was provided by the initial reporter: some tubes are pink colour and some are turbid in the current lot number.

• Brand Name: BD PHOENIX¿ AST BROTH
• Type of Device: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• 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: 15108793
• MDR Text Key: 301260154
• Report Number: 1119779-2022-01026
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 30382902460030
• UDI-Public: 30382902460030
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K020321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/24/2022
• Device Model Number: 246003
• Device Catalogue Number: 246003
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2021
• 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