MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ CHOCOLATE II AGAR, 100 PLATES; CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

Catalog Number 251267

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is fukushima.This site is an oem manufacturing site.Therefore, bd corporate headquarters in sparks, md has been listed in sections d.3.And g.1.And the sparks fda registration number has been used for the manufacture report number.B3: date of event is unknown.The date received by manufacturer has been used for this field.G5.There is no 510(k) for this device as it is manufactured outside the us and not sold in the us, but it is considered to be substantially similar to the legally u.S.Marketed device bd bbl¿ chocolate ii agar (gc ii agar with hemoglobin and isovitalex¿), catalog number 221267 with 510k # preamendment.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that prior to using bd bbl chocolate ii agar, 100 plates, there was no label on plates, total quantity is one box.No patient impact reported.The following information was provided by the initial reporter: "typographical error, total quantity 1 box.".

Manufacturer Narrative

H.6.Investigation summary: 251267 #3178139 we could confirm this issue as a report from photo.This issue was print defect.No issue in retention sample.No issue in dhr at all (including jet printer).Root cause was undetermined.No complaint history.H3 other text : see h.10.

Event Description

It was reported that prior to using bd bbl chocolate ii agar, 100 plates, there was no label on plates, total quantity is one box.No patient impact reported.The following information was provided by the initial reporter: "typographical error, total quantity 1 box.".

• Brand Name: BD BBL¿ CHOCOLATE II AGAR, 100 PLATES
• Type of Device: CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17991323
• MDR Text Key: 326364467
• Report Number: 1119779-2023-01170
• Device Sequence Number: 1
• Product Code: JTY
• UDI-Device Identifier: 30382902512678
• UDI-Public: (01)30382902512678
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

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: 10/23/2023
• Device Catalogue Number: 251267
• Device Lot Number: 3178139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• 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