MAUDE Adverse Event Report: BECTON DICKINSON GMBH PLATE CAMPY BF SELECTIVE MEDIUM 90MM 20; MEDIA_PPM_HEIDELBERG

Catalog Number 254403

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that while using plate campy bf selective medium 90mm 20 atypical growth was observed by the laboratory personnel.There was no report of serious injury or medical intervention.

Event Description

It was reported that while using plate campy bf selective medium 90mm 20 atypical growth was observed by the laboratory personnel.There was no report of serious injury or medical intervention.

Manufacturer Narrative

H.6.Investigation: this statement is to summarize findings on the recent complaint against campylobacter bloodfree selective medium, catalog number 254403, lot number 0339653.Event description: it was reported that smear instead of separated colonies would appear on the plates.Complaint history review: the complaint history was reviewed.During this period, no further complaints were reported for this product for performance related issues.Therefore, a trend could not be identified.Batch history record (bhr) review: the batch history record review did not show any discrepancies.Sample analysis: picture sample was provided showing colonies on the plates.An analysis of growth promotion for the media was performed on retention samples for the following strains: ca.Jejuni jejuni atcc 33291.Ca.Fetus fetus dsm 5361.Resulted in excellent growth of colonies after an incubation of 48 hours at 36 ± 1°c in a microaerophil atmosphere.Also.E.Coli atcc 25922.P.Mirabilis atcc 14153.E.Faecalis atcc 29212.Resulted in inhibition after an incubation time of 72 hours at 36 ± 1°c in a microaerophil atmosphere.Evaluation results: at this stage of our investigation, we have excluded any systemic failure in our production process.The qc performance test was performed without any deviations.Investigation conclusion: based on the evaluation of the reports, and the qc performance test the complaint was not confirmed.We would suggest that any prepared plated media is set aside and not used that does not meet the appearance specification as it is described on the bd certificate of analysis.This is consistent with industry recommendations for inspection of culture media prior to use (e.G.¿good practices for pharmaceutical microbiology laboratories¿, who technical report series, no.(b)(6) , annex 2; chapter <1117> ¿microbiology best laboratory practices¿ the united states pharmacopeia; and the difco & bbl manual).H3 other text : see h.10.

• Brand Name: PLATE CAMPY BF SELECTIVE MEDIUM 90MM 20
• Type of Device: MEDIA_PPM_HEIDELBERG
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11294170
• MDR Text Key: 278785131
• Report Number: 9680577-2021-00006
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 11/05/2021

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: 03/01/2021
• Device Catalogue Number: 254403
• Device Lot Number: 0339653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2020
• 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