MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL BOTTLED MEDIA 500ML

Catalog Number 299111

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that prior to use with bd bbl¿ bottled media 500ml the shipper was missing product label.

Event Description

Was reported that prior to use with bd bbl¿ bottled media 500ml the shipper was missing product label.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 1119779-2021-00150 was sent in error.This product is luo, therefore, this is not considered to be reportable.

• Brand Name: BD BBL BOTTLED MEDIA 500ML
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11239903
• MDR Text Key: 230473120
• Report Number: 1119779-2021-00150
• Device Sequence Number: 1
• Product Code: JSC
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 299111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1