MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD. XLD AGAR (XYLOSE-LYSINE-DESOXYCHOLATE AGAR); CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Catalog Number 254055

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 04/15/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: it was reported plates that were found with candida species in or between the medium the complaint history record for a period of 12 months has been checked and another similar complaint related to this batch was recorded.However no trend was identified.The batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.The retain samples have been checked and crystals could be observed on some samples.No return samples were provided however the shared pictures were illustrating the complained failure mode.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 (sterility assurance level) claim.It is filled aseptically, therefore an occurrence of a contamination event cannot be entirely ruled out.Based on the above mentioned evaluation, the complaint can be confirmed for crystals.However as no trend was identified, a corrective and preventive action will not be initiated.

Event Description

It was reported that while using bd.Xld agar (xylose-lysine-desoxycholate agar) contamination - biological contamination - bacterial, fungal, non-viable was observed.There was no patient impact reported.The following information was provided by the initial reporter.The customer stated: "these images are reminiscent of candida species.Appears to be in or between the medium.".

Manufacturer Narrative

After further evaluation of the complaint this product is not registered or sold in the us.Therefore an mdr is not required.This supplemental report is to cancel the initial mdr.Mfr report # : 9680577-2022-00066.

Event Description

It was reported that while using bd.Xld agar (xylose-lysine-desoxycholate agar) contamination - biological contamination - bacterial, fungal, non-viable was observed.There was no patient impact reported.The following information was provided by the initial reporter.The customer stated: "these images are reminiscent of candida species.Appears to be in or between the medium.".After further evaluation of the complaint this product is not registered or sold in the us.Therefore an mdr is not required this supplemental report is to cancel the initial mdr.Mfr report # : 9680577-2022-00066.

• Brand Name: BD. XLD AGAR (XYLOSE-LYSINE-DESOXYCHOLATE AGAR)
• Type of Device: CULTURE MEDIA, SELECTIVE AND 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: 14403677
• MDR Text Key: 300147463
• Report Number: 9680577-2022-00066
• Device Sequence Number: 1
• Product Code: JSI
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: EXEMPT
• 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: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/02/2022
• Device Catalogue Number: 254055
• Device Lot Number: 2038267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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