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

Model Number 246003

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: this complaint is for contamination of phoenix ast broth tubes (246003) batch 0274317.The customer did provide photos for investigation, but no sample returns.The photos showed foreign matter inside the broth of 2 tubes.To further investigate, a box of retention tubes from the complaint batch were manually visually inspected for any sort of contamination in or on the tubes.0/100 tubes from retention were observed for any contamination or in or on the tubes.Based on 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 this batch.Complaint trending was performed and no trends were identified associated with this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.Please continue to communicate any additional concerns.

Event Description

It was reported that while using bd phoenix¿ ast broth contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "contaminated jars.".

• Brand Name: BD PHOENIX AST BROTH
• 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: 12277426
• MDR Text Key: 265602077
• Report Number: 1119779-2021-01284
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 30382902460030
• UDI-Public: 30382902460030
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 07/20/2021

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 Model Number: 246003
• Device Catalogue Number: 246003
• Device Lot Number: 0274317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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