MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ MUELLER HINTON II AGAR 150MM PLATE 24PK; SEE H.10

Catalog Number 254518

Device Problem Contamination (1120)

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

Event Date 01/17/2023

Event Type  malfunction  

Manufacturer Narrative

Common device name: culture media, antimicrobial susceptibility test, mueller hinton agar/broth.Initial reporter phone: (b)(6).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 bd bbl¿ mueller hinton ii agar 150mm plate 24pk were found contaminated before use.The following information was provided by the initial reporter: plates were contaminated before use, customer suspects bacillus sp.

Manufacturer Narrative

H6 investigation summary: event description: the customer reported plates were contaminated before use.Complaint history review: complaint history was reviewed and no similar complaint was 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 the issue could not be observed.Neither picture nor return samples were provided.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 the review of the review of the batch history record.Since neither picture nor return were provided no further investigation could be performed.Investigation conclusion: based on the above mentioned evaluation, the complaint cannot be confirmed.However will continue to monitor incoming complaints for similar defect types.H3 other text : see h.10.

Event Description

It was reported that bd bbl¿ mueller hinton ii agar 150mm plate 24pk were found contaminated before use.The following information was provided by the initial reporter: plates were contaminated before use, customer suspects bacillus sp.

• Brand Name: BD BBL¿ MUELLER HINTON II AGAR 150MM PLATE 24PK
• Type of Device: SEE H.10
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16277860
• MDR Text Key: 308616110
• Report Number: 9680577-2023-00003
• Device Sequence Number: 1
• Product Code: JTZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: NA
• 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: 02/16/2023

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: 03/15/2023
• Device Catalogue Number: 254518
• Device Lot Number: 2334251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 02/16/2023
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1