MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ GC II AGAR WITH ISOVITALEX; PLATE CHOCO GC AG W/ISOVITALEX 90MM 20

Catalog Number 254060

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

H.6.Investigation summary: event description: the customer reported when they spike the urine on chocolat (urine with leuco which remains sterile on ori) regularly burkholderia was found.Complaint history review: complaint history was reviewed, and similar complaints were identified for this catalog number.However, no trend was identified.Batch history record (bhr) review: the batch history record was reviewed, and no discrepancy was detected.Sample analysis: the retain samples were reviewed and no deviation was detected.Neither picture nor return samples were provided for further analysis by the customer.Evaluation results: after investigations, no deviation could be detected in our validated manufacturing process.No deviation could be detected neither during the review of the retain samples nor during review of the batch history record.This product is filled under aseptic conditions.Therefore, sterility of the finished product cannot be guaranteed.Unfortunately, a 100 % inspection level for sterility is not possible and sterility testing is carried out based on a representative sample.In consequence, occasional contamination cannot be prevented by 100%; although the contamination rate remains below the acceptance level.A definite root cause was not identified.H3 other text : see h.10.

Event Description

It was reported that while using bd bbl¿ gc ii agar with isovitalex, customer found burkholderia when spiked the urine on chocolate.This event occurred 1 time.The following information was provided by the initial reporter: when we spike our urine on chocolate (urine with leuco which remains sterile on ori) we regularly find burkholderia!!!! - did the problem have a negative impact on patient outcomes? yes difficulty interpreting records - if yes, were any erroneous results reported to the clinician? impossible to quantify.

• Brand Name: BD BBL¿ GC II AGAR WITH ISOVITALEX
• Type of Device: PLATE CHOCO GC AG W/ISOVITALEX 90MM 20
• Manufacturer (Section D): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer (Section G): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer Contact: jennifer suh ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18029772
• MDR Text Key: 326854058
• Report Number: 9680577-2023-00045
• Device Sequence Number: 1
• Product Code: JSO
• UDI-Device Identifier: 30382902540602
• UDI-Public: (01)30382902540602
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K945569
• 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
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/16/2023
• Device Catalogue Number: 254060
• Device Lot Number: 3199076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• 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