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

Model Number 246003

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: this complaint is for contaminated tubes of phoenix ast broth (246003) batch 0274314.The customer provided multiple photos for investigation.The photos show a cloudy white substance floating in the centers of the tube within the broth on multiple tubes.Due to the photos provided for investigation, this complaint is confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed no additional complaints on the complaint batch.Complaint trending was performed and no trends were identified for this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.

Event Description

It was reported that 20 bd phoenix" ast broth tubes had white, flocculent sediment in them.There was no indication that results were reported, and there was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: "in march, the hospital purchased tube phoenix ast broth sp100 cat#246003, and there were 20 pieces tube phoenix ast broth sp100 in one box had flocculent sediment, like white bacteria, so the hospital kept 7 pieces for returning to the company.".

• Brand Name: BD PHOENIX AST BROTH
• Type of Device: AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY SYSTEM TEST
• 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: 12569300
• MDR Text Key: 274575253
• Report Number: 1119779-2021-01603
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 30382902460030
• UDI-Public: 30382902460030
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K020321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/28/2021
• Device Model Number: 246003
• Device Catalogue Number: 246003
• Device Lot Number: 0274314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• 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