MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD PLATE CAMPYLOBACTER SB 100MM; CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 217250

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

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

Event Date 05/04/2022

Event Type  malfunction  

Event Description

It was reported that 20 plates of bd plate campylobacter sb 100mm were inhibiting the expected growth of enterobacteria.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: the medium is not inhibiting the enterobacteria, and is causing them to grow in the medium.Is this problem found in the patient's sample or quality control? in all processed patient samples, enterobacteria were not inhibited so campylobacter could not be identified.If the samples are from the patient: were erroneous results reported to the health care provider? no.If yes, were any patients treated based on the wrong results? n/a.Were there any other adverse impacts on the patient? none.

Manufacturer Narrative

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¿ campylobacter agar w/5 antimicrobics and 10% sheep blood catalog number 221727 with 510k number k800541.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: the complaint was created due to a report from catalog 217250 plate campylobacter sb 100mm 10ea lot 2083771.The customer reports that the medium is not inhibiting enterobacteriaceae, and is increasing growth on the medium.Review of history of claims: the list of claims was reviewed in a period of two previous years and no reports related to the batch reported by default indicated by the client were found.Review of the batch file: the notified batch file was reviewed verifying that all the processes were followed effectively during the manufacture of the product.Analysis of client samples: the client sends 3 photographs, where in two of them the informed lot is confirmed, in the third the defect reported by the client is shown.Analysis of retention samples: the retention samples were analyzed by the quality control department, observing that the physical state of the samples is in compliance with their appearance characteristics.A growth support analysis was performed, resulting satisfactory.The acceptance criteria in the final inspection were satisfactory with respect to those selected.Conclusion: the notified batch file was reviewed verifying that all the processes were followed effectively during the manufacture of the product, likewise the batch was analyzed by the quality control department and the results were satisfactory for the release of the batch.The retention samples were inspected and showed a bright red color and an opaque appearance, both acceptable according to the selected criteria.A support test was carried out to obtain satisfactory inhibition results, as indicated in the analysis certificate.Derived from the investigation, it is concluded that the product is within specifications and complies with its intended use.It is not possible to determine a root cause of the report as the defect cannot be identified.

Event Description

It was reported that 20 plates of bd plate campylobacter sb 100mm were inhibiting the expected growth of enterobacteria.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: the medium is not inhibiting the enterobacteria, and is causing them to grow in the medium.Is this problem found in the patient's sample or quality control? in all processed patient samples, enterobacteria were not inhibited so campylobacter could not be identified.If the samples are from the patient: o were erroneous results reported to the health care provider? no o if yes, were any patients treated based on the wrong results? n/a o were there any other adverse impacts on the patient? none.

• Brand Name: BD PLATE CAMPYLOBACTER SB 100MM
• Type of Device: CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14580432
• MDR Text Key: 300924076
• Report Number: 9614033-2022-00046
• Device Sequence Number: 1
• Product Code: JSJ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K800541
• 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: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/19/2022
• Device Catalogue Number: 217250
• Device Lot Number: 2083771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• 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