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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ HAEMOPHILUS TEST MEDIUM AGAR; CULTURE MEDIA, ANTIMICROBIAL SUSCEP TEST, EXCL MUELLER HINTON
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BECTON DICKINSON GMBH BD BBL¿ HAEMOPHILUS TEST MEDIUM AGAR; CULTURE MEDIA, ANTIMICROBIAL SUSCEP TEST, EXCL MUELLER HINTON Back to Search Results
Catalog Number 254058
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2021
Event Type  malfunction  
Event Description
It was reported that while using bd bbl¿ haemophilus test medium agar 2 plates had no colony growth.The following information was provided by the initial reporter: no colony growth on plate 2 plates were tested from a positive blood culture but there was no colony growth after incubation in co2.
 
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¿ haemophilus test medium agar (htm agar) catalog number 221954 with 510k number k894216b.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that while using bd bbl¿ haemophilus test medium agar 2 plates had no colony growth.The following information was provided by the initial reporter: no colony growth on plate 2 plates were tested from a positive blood culture but there was no colony growth after incubation in co2.
 
Manufacturer Narrative
H.6.Investigation: this statement is to summarize findings on the recent complaint against haemophilus test medium agar (htm), catalog number 254058, lot number 1257478 with respect to poor growth of haemophilus influenzae.Event description: it was reported that haemophilus influenzae showed poor growth on the affected medium.The performed control using atcc strains showed poor growth as well.Complaint history review: the complaints trends were reviewed for a period covering 12 months.There are additional two complaints for poor growth of haemophilus sp.Strains currently under investigation.In addition, there are currently a total of six complaints under investigation regarding the same issue under investigation.Batch history record (bhr) review: the batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.Sample analysis: return samples and pictures were not provided by the customer.Retain samples for batch 1257478 were analyzed.The qc department performing the analysis could confirm the complaint for poor growth of h.Influenzae.Evaluation results: since the bhr showed no deviations we have excluded any systemic failure in our manufacturing process.Because a complaint trend could be identified, bd has set up an internal investigation which is currently ongoing.A definite root cause is not identified yet.Investigation conclusion: based on our evaluation we can confirm this complaint for poor growth of h.Influenzae.Bd will continue to monitor for complaints regarding material number 254058.We would suggest to set aside and not use any prepared plated media 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.961, 2011, annex 2; chapter <1117> ¿microbiology best laboratory practices¿ the united states pharmacopeia; and the difco & bbl manual).H3 other text : see h.10.
 
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Brand Name
BD BBL¿ HAEMOPHILUS TEST MEDIUM AGAR
Type of Device
CULTURE MEDIA, ANTIMICROBIAL SUSCEP TEST, EXCL MUELLER HINTON
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 Key12780185
MDR Text Key285054520
Report Number9680577-2021-00076
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K894216B
Number of Events Reported1
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 11/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/08/2021
Device Catalogue Number254058
Device Lot Number1257478
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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