MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM AGAR); 2PREPARED MEDIA

Catalog Number 254058

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

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

Event Date 10/20/2021

Event Type  malfunction  

Event Description

It was reported that while using bd bbl¿ haemophilus test medium agar (htm agar) there was a performance issue resulting in no growth.This was the only stated occurrence.No additional testing was mentioned.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: update 10/25/2021: was this with patient samples or qc? patient.If patient samples - need to know if there was any erroneous results and if so - were any reported out on the patients.Were they treated based on the erroneous results? no erroneous result reported.Did this lot work previously? it was first time this customer receives this lot.Haemophilus for disc difussion does not grow.

Manufacturer Narrative

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¿ haemophilus test medium agar (htm agar) catalog number 221954 which has 510k number k894216b.

Event Description

It was reported that while using bd bbl¿ haemophilus test medium agar (htm agar) there was a performance issue resulting in no growth.This was the only stated occurrence.No additional testing was mentioned.There was no indication that results were reported out, and there was no patient impact.The following information was provided by the initial reporter: update 10/25/2021: was this with patient samples or qc? patient.If patient samples - need to know if there was any erroneous results and if so - were any reported out on the patients.Were they treated based on the erroneous results? no erroneous result reported.Did this lot work previously? it was first time this customer receives this lot.Haemophilus for disc diffusion does not grow.

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, (b)(4) ¿microbiology best laboratory practices¿ the united states pharmacopeia; and the difco & bbl manual).

• Brand Name: BD BBL¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM AGAR)
• Type of Device: 2PREPARED MEDIA
• 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: 12817136
• MDR Text Key: 285352032
• Report Number: 9680577-2021-00079
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K894216B
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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 Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/08/2021
• Device Catalogue Number: 254058
• Device Lot Number: 1257478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• 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