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

Catalog Number 257303

Device Problem Contamination (1120)

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

Event Date 03/03/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).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¿ columbia cna agar with 5% sheep blood catalog number 221352 which is a preamendment device.Investigation summary: it was reported that 35 plates would have show contamination.The complaint trends were reviewed and similar complaints were found for this lot number.Therefore, a mrb (material review board) was performed and the results were documented within a cid (corrective and preventive action initiation determination).The batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.Pictures were provided showing the reported contamination.The retention samples were reviewed and one plate with contamination was detected.At this stage of our investigation, we have excluded any systemic failure in our manufacturing process.Please note that this product does not have an sal claim.It is filled aseptically, therefore an occurrence of a contamination event cannot be entirely ruled out.We only release product batches to the market with an aql (acceptable quality level) = 1.5.Although this contamination level is very low, we cannot completely exclude that a customer may receive a contaminated plate.As several complaints were reported for this product lot number regarding contamination, further evaluation will be conducted via cid.As a root cause it could be identified that the blood pool which was used during a timely isolated production frame was contaminated.The contaminant which was also identified on one plate in the retain samples, is easy detectable as it grows before incubation.

Event Description

It was reported that while using 35 bd bbl¿ (b)(6) cna 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: "when they opened the boxes they realized that there were about 35 contaminated plates.".

• Brand Name: BD BBL¿ COLUMBIA CNA 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13959620
• MDR Text Key: 290149342
• Report Number: 9680577-2022-00043
• Device Sequence Number: 1
• Product Code: JSJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PREAMENDMENT
• 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
• Report Date: 03/28/2022

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: 03/31/2022
• Device Catalogue Number: 257303
• Device Lot Number: 2004161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2022
• Initial Date FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• 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