MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ HAEMOPHILUS TEST MEDIUM AGAR 20 EA; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON

Catalog Number 252037

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

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

Event Date 12/16/2023

Event Type  malfunction  

Manufacturer Narrative

E1 initial reporter facility name: (b)(6) medical center.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.The manufacturing location for this product is (b)(6), japan.This site is an oem manufacturing site.Therefore, bd ds 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.

Event Description

It was reported when using bd bbl¿ haemophilus test medium agar 20 ea that bacteria growth was weakened.There was no health impact or consequences reported.

Event Description

It was reported when using bd bbl¿ haemophilus test medium agar 20 ea that bacteria growth was weakened.There was no health impact or consequences reported.

Manufacturer Narrative

H6: investigation summary: bd had not received samples or photos for investigation.Therefore, retention samples from bd inventory were evaluated and no issues were observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for insufficient growth.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

• Brand Name: BD BBL¿ HAEMOPHILUS TEST MEDIUM AGAR 20 EA
• Type of Device: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18505158
• MDR Text Key: 333318295
• Report Number: 1119779-2024-00023
• Device Sequence Number: 1
• Product Code: JSO
• UDI-Device Identifier: 00382902520375
• UDI-Public: (01)00382902520375
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K894216
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/01/2024
• Device Catalogue Number: 252037
• Device Lot Number: 3248233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• 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