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

Model Number 246004

Device Problem Expiration Date Error (2528)

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd phoenix¿ ast indicator solution incorrect label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "the outer box and inner packaging date are different.".

Manufacturer Narrative

H6: investigation summary: this complaint is for the incorrect expiration date on the foil pouch of phoenix ast indicator (246004) batch 1105781.The customer did return multiple photos which showed the pouch with a date of 04-30-2020 when the correct expiration date is 04-30-2022.The photos also showed the bottle which displayed the correct expiration date of 04-30-2022.To investigate further the expiration date was verified along with manufacture date.It was determined that the expiration of 04-30-2022 was the correct date of expiration and that the product was useable.Based on the photos provided this complaint is confirmed.A review of quality notifications revealed one quality notification generated on the complaint batch, qn (b)(4).A review of complaints was performed and there were fifteen additional complaints filed for this batch not all for the same defect.A complaint trend was identified for this defect.Based on the severity and rate, a corrective and preventive action (capa) investigation was not initiated.H3 other text : see h10.

Event Description

It was reported that while using bd phoenix¿ ast indicator solution incorrect label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "the outer box and inner packaging date are different.".

• Brand Name: BD PHOENIX¿ AST INDICATOR SOLUTION
• Type of Device: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12305322
• MDR Text Key: 266014841
• Report Number: 1119779-2021-01346
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 30382902460047
• UDI-Public: 30382902460047
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Report Date: 12/02/2021

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
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Model Number: 246004
• Device Catalogue Number: 246004
• Device Lot Number: 1105781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1