MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL TRYPTICASE SOY AGAR, HEAVY FILL STERILE

Catalog Number 292396

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2020

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.(b)(4).

Event Description

It was reported while using bd bbl¿ trypticase¿ soy agar, heavy fill sterile 10 boxes failed growth promotion.Customer conducted investigation, however, it was inconclusive.

Manufacturer Narrative

After further review it has been determined that mfr#:1119779-2021-00263 was sent in error.The product in question is luo and was used in a qc environment and is not considered to be a reportable malfunction.As a result mfr#:1119779-2021-00263 is null and void.

Event Description

It was reported while using bd bbl¿ trypticase¿ soy agar, heavy fill sterile 10 boxes failed growth promotion.Customer conducted investigation, however, it was inconclusive.

• Brand Name: BD BBL TRYPTICASE SOY AGAR, HEAVY FILL STERILE
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11293515
• MDR Text Key: 232013351
• Report Number: 1119779-2021-00263
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

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: 03/04/2021
• Device Catalogue Number: 292396
• Device Lot Number: 0261717
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1