MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ PSEUDOSEL¿ AGAR; CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Catalog Number 297882

Device Problem Contamination (1120)

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

Event Date 06/06/2022

Event Type  malfunction  

Manufacturer Narrative

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, one sleeve of bd bbl¿ pseudosel¿ agar plates was contaminated.The following information was provided by the initial reporter: customer reports that bd bbl¿ pseudosel¿ agar (cetrimide agar) plate 10pk "297882" lot # 2126082" is contaminated.

Manufacturer Narrative

This supplemental mdr is to cancel mfr report #1119779-2022-00945.Clarifying information was provided by the customer: plates were not contaminated.They failed a qc test for growth.The following information was provided by the initial reporter: "pseudosel (cetrimide) agar, lot 2126082 was received on 25may2022 and growth promotion testing and contamination check testing were initiated on 25may2022.Growth promotion testing failed due to no growth for atcc 9027 on the pseudosel plates lot 2126082.Testing was repeated, and confirmed that lot 2126082 had no growth for atcc 9027.All inoculation verification plates met acceptance criteria, rendering the tests valid.The contamination check for lot 2126082 met the acceptance criteria.".

Event Description

It was reported that prior to use, one sleeve of bd bbl¿ pseudosel¿ agar plates was contaminated.The following information was provided by the initial reporter: customer reports that bd bbl¿ pseudosel¿ agar (cetrimide agar) plate 10pk "297882" lot # 2126082" is contaminated.

• Brand Name: BD BBL¿ PSEUDOSEL¿ AGAR
• Type of Device: CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14876407
• MDR Text Key: 303317328
• Report Number: 1119779-2022-00945
• Device Sequence Number: 1
• Product Code: JSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/24/2022
• Device Catalogue Number: 297882
• Device Lot Number: 2126082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2022
• 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