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

Model Number 246006

Device Problem Illegible Information (4050)

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

Event Date 08/09/2022

Event Type  malfunction  

Event Description

It was reported that prior to use with the bd phoenix¿ ap ast indicator solution, the label was damaged and the device catalog number was not legible.The number of bottles affected is unknown.The following information was provided by the initial reporter: customer described leakage of the ap ast indicator in the pouches.No significant loss, but watched as a new one was open and like the one being removed the label was defaced with the blue color of the indicator.There has been no impact to instrument performance or patient results.

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: this complaint is for leaking phoenix ap ast indicator (246006) batch number 1348700.The photo showed an indicator bottle with indicator on the outside of the bottle and on the label.Additionally, five (5) retention samples were visually inspected for leaking and one bottle was found to be leaking.No samples were returned.Based on the photo provided and the retention checks, this complaint is confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed one additional complaint on the complaint batch related to this issue.Complaint trending was performed, and a complaint trend was identified for this defect february 2022.To determine if a corrective and preventive action (capa) was required, a capa initiation determination (cid) was performed, and based on the occurrence and severity of this issue, a capa was deemed necessary.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.Please continue to communicate any additional concerns.Per baltrmphxidastaph rev 10 version h, id 15.1, a defective product obvious to user has a severity assessment of s1.

Event Description

It was reported that prior to use with the bd phoenix¿ ap ast indicator solution, the label was damaged and the device catalog number was not legible.The number of bottles affected is unknown.The following information was provided by the initial reporter: customer described leakage of the ap ast indicator in the pouches.No significant loss, but watched as a new one was open and like the one being removed the label was defaced with the blue color of the indicator.There has been no impact to instrument performance or patient results.

• Brand Name: BD PHOENIX¿ AP AST INDICATOR SOLUTION
• 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: 15204005
• MDR Text Key: 305260737
• Report Number: 1119779-2022-01092
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 30382902460061
• UDI-Public: 30382902460061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020321
• 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: 10/20/2022

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 Expiration Date: 12/31/2022
• Device Model Number: 246006
• Device Catalogue Number: 246006
• Device Lot Number: 1348700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 10/20/2022
• Supplement Dates FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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