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

Catalog Number 254518

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

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

Event Date 01/27/2023

Event Type  malfunction  

Event Description

It was reported that bd bbl¿ mueller hinton ii agar 150mm plate 24pk insufficient growth occurred.The following information was provided by the initial reporter: during use the bacterial growth take place only on half plate and therefore the mic determination is impossible to detect.

Manufacturer Narrative

Date of event is unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot#: 2259870, medical device expiration date: 05-jan-2023, device manufacture date: 16-sep-2022.Medical device lot#: 2237517, medical device expiration date: 15-dec-2022, device manufacture date: 25-aug-2022.Common device name: culture media, antimicrobial susceptibility test, mueller hinton agar/broth.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Initial reporter email: (b)(6).Initial reporter facility name: (b)(6).

Event Description

It was reported that bd bbl¿ mueller hinton ii agar 150mm plate 24pk insufficient growth occurred.The following information was provided by the initial reporter: during use the bacterial growth take place only on half plate and therefore the mic determination is impossible to detect.

Manufacturer Narrative

H6 investigation summary: event description: the customer reported the bacterial growth take place only on half plate.Complaint history review: complaint history was reviewed and no similar complaint was identified for this catalog number.Batch history record (bhr) review: the batch history record was reviewed and no discrepancy was detected.Sample analysis: retains samples were no longer available since the complaint was raised after the expiry date of product.Return samples were not provided however pictures illustrating a plate with a partial bacterial growth were shared.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 in process control nor during the review of the batch history record.The release data of the complained batches were checked and all the values were meeting the specification.The retain samples could not be tested since the complaint was raised after the expiry date of the product.

• 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 ; 8448235433
• MDR Report Key: 16429472
• MDR Text Key: 310373456
• Report Number: 9680577-2023-00006
• Device Sequence Number: 1
• Product Code: JTZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/24/2023

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: 12/15/2022
• Device Catalogue Number: 254518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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