MAUDE Adverse Event Report: BECTON DICKINSON GMBH PLATE SABOURAUD AGAR W/GENT W/CHMP 90MM; CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 254096

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.There is no 510(k) for this device as it is manufactured outside the us and not sold in the us but is considered to be substantially similar to the legally u.S.Marketed device bd bbl" sabouraud dextrose agar with chloramphenicol and gentamicin deep fill catalog number 296359 which is a class 1, 510(k) exempt device.

Event Description

It was reported that while using plate sabouraud agar w/gent w/chmp 90mm mold contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: '' in relation to order no.32214630 of 19/05/2021 we found on the sabouraud product lot 1112582 exp.23/07/2021 the presence of mold contamination inside the plates still sealed and properly stored.''.

Manufacturer Narrative

H6: investigation summary: this statement is to summarize findings on the recent complaint 3171962 against sabouraud agar with gentamicin and chloramphenicol, catalog number 254096, lot number 1112582.Event description: it was reported that the plates were found to be contaminated in their unopened sleeves.Complaint history review: complaint history of the affected batch and catalog number was reviewed for the past 12 months.There were no similar complaints registered.Therefore a trend could not be identified.Dhr review: the bhr was reviewed.No deviations from validated processes were registered.Furthermore the affected batch met all required release specifications and no deviation was registered during qc release testing.Sterilization record review: the medium itself is heat sterilized.However, this product is filled under aseptic conditions.Since a 100 % control for sterility is not possible a representative sampling is done by the qc department.Lot no.1112582 complied to our internal acceptance quality limit (aql) for sterility.Sample analysis: a picture sample was not provided for further evaluation.A picture sample was not provided for further evaluation.Investigation conclusion: aseptic manufacturing processes are unable to guarantee sterility of the given product.Since a 100 % inspection is not possible for aseptic products, sterility testing carried out on the basis of a representative sample.Therefore, occasional contamination cannot be prevented.Nevertheless, to improve customer experience, an interdisciplinary team was founded to further reduce the occurrence of these subliminal contaminations.Effectiveness checks indicate a significant improvement to the situation caused by the triggered actions.Bd will continue to monitor incoming complaints for similar defect types.Evaluation results: based on the internal investigation and as no pictures were provided, the complaint was not confirmed.Neither a trend nor a definite root cause could not be identified.

Event Description

It was reported that while using plate sabouraud agar w/gent w/chmp 90mm mold contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " in relation to order no.(b)(4) of 19/05/21 we found on the sabouraud product lot 1112582 exp.23/07/2021 the presence of mold contamination inside the plates still sealed and properly stored.".

• Brand Name: PLATE SABOURAUD AGAR W/GENT W/CHMP 90MM
• Type of Device: CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12215035
• MDR Text Key: 267306515
• Report Number: 9680577-2021-00033
• Device Sequence Number: 1
• Product Code: JSJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• 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: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/23/2021
• Device Catalogue Number: 254096
• Device Lot Number: 1112582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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