MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD BBL¿ THIOGLYCOLLATE MEDIUM; MULTIPURPOSE CULTURE MEDIUM

Catalog Number 221742

Device Problems Material Opacification (1426); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2019

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 bd bbl¿ thioglycollate medium was cloudy and contaminated with gram-negative rods.The customer indicated that 15 different patient samples did not exhibit signs of bacterial growth in culture media.The physicians were notified but unable to determine if any patients had been treated or treatment changed due to the erroneous results.Customer is investigating and bd will continue to make the necessary follow-up attempts to gain further information.

• Brand Name: BD BBL¿ THIOGLYCOLLATE MEDIUM
• Type of Device: MULTIPURPOSE CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 250 schilling circle; cockeysville MD 21030
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 250 schilling circle; cockeysville MD 21030
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8760215
• MDR Text Key: 150268077
• Report Number: 1111096-2019-00102
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902217429
• UDI-Public: 30382902217429
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803023
• 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
• Report Date: 07/03/2019

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: 03/28/2019
• Device Catalogue Number: 221742
• Device Lot Number: 9087634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2019
• 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
• Patient Outcome(s): Other