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 (1120)

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

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd bbl¿ schaedler k-v agar with 5% sheep blood contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "one package cannot be used and must be discarded, due to contamination".

Manufacturer Narrative

Investigation summary: this memo is to summarize findings on your recent complaint (b)(4) against plate schaedler agar / schaedler kv agar with 5% sheep blood (biplate) catalog number 257589, lot number 1104468.It was reported that one box of plates would show contaminaton.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.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.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.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.H3 other text : see h10.

Event Description

It was reported that while using bd bbl¿ schaedler k-v agar with 5% sheep blood contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "one package cannot be used and must be discarded, due to contamination".

• 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: 12124629
• MDR Text Key: 264047829
• Report Number: 9680577-2021-00029
• 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
• 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: 07/06/2021
• 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
• Patient Sequence Number: 1