MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD BBL¿ SCHAEDLER K-V AGAR WITH 5% SHEEP BLOOD; CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 257589

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 for this field.Initial reporter phone #: (b)(6).Initial reporter fax #: (b)(6).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 prior to use bd bbl¿ 50 plates of schaedler k-v agar with 5% sheep blood they were discovered to be contaminated.The following information was provided by the initial reporter, translated from (b)(6) to english: the schaedler / schaed kv + 5% sb biplate agar plate was heavily contaminated and could not be used.

Event Description

It was reported that prior to use bd bbl¿ 50 plates of schaedler k-v agar with 5% sheep blood they were discovered to be contaminated.The following information was provided by the initial reporter, translated from german to english: the schaedler / schaed kv + 5% sb biplate agar plate was heavily contaminated and could not be used.

Manufacturer Narrative

H6: investigation summary: this statement is to summarize findings on the recent complaint 3137508 against schaedler agar / schaedler kv agar with 5% sheep blood (biplate), catalog number 257589, lot number 1104468.Event description: it was reported that 50 plates would have show contamination.Complaint history review: the complaint trends were reviewed for a period covering 12 months.For this product, several complaints were reported for contamination issues.Therefore, a trend was identified, and further investigation was performed.Batch history record (bhr) review: the batch history review was performed.As part of the investigation, the ingredients of this medium were reviewed.During this review, no deviation was detected.Sample analysis: picture sample was provided for evaluation.Based on the picture, the schaedler agar side was found to be contaminated.Retain samples were reviewed for this lot.During this review, contamination could be detected.Evaluation results: at this stage of our investigation, we have excluded any systemic failure in our manufacturing process.A material review board (mrb) was conducted which led to a situation analysis (sa) which eventually resulted in a recall.The performed investigation showed that the origin of the contamination was associated with an anaerobic microorganism growing at lower temperatures (<22°c).This microorganism was detected for the first time at the production site.Therefore, and as no contamination complaints were received in conjunction with the respective product within the past year this event was concluded to be a single incident.However, regarding the reported contamination, please note that this product does not have an sal (sterility assurance level) claim.It is filled aseptically, therefore an occurrence of a contamination event cannot be entirely ruled out.Investigation conclusion: based on the evaluation of the report the complaint is confirmed.An mrb was initiated and a sa was performed for contamination issue, which led to a recall.We would suggest that you 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).

• Brand Name: BD BBL¿ SCHAEDLER K-V AGAR WITH 5% SHEEP BLOOD
• 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: 12197701
• MDR Text Key: 262912774
• Report Number: 9680577-2021-00032
• Device Sequence Number: 1
• Product Code: JSJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K760460
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/15/2021
• Device Catalogue Number: 257589
• Device Lot Number: 1104468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: IDS-21-4201
• Patient Sequence Number: 1