MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BBL¿ TAXO¿ A DISCS FOR DIFFERENTIATION OF GROUP A STREPTOCOCCI; DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

Model Number	231042
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one bd bbl¿ taxo¿ a discs for differentiation of group a streptococci was contaminated.There was no patient impact.The following information was provided by the initial reporter: contamination noticed after inoculation.No patient samples affected - "we were doing proficiency testing and an a/b plate." customer is not qualified to identify the contamination.Colony color is white.
Additional Manufacturer Narrative
H3: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6.Investigation summary: a complaint investigation due to contamination with taxo a catalog 231042 batch no.: 2003421 was performed on retention samples.Returned goods were not received from customer.The investigation required to test product for performance, contamination, visual inspection, and batch record review.Retention samples performed as expected.No discrepancies observed during the visual inspection.Batch record review did not show any evidence of customer claim.Photos received from customer were evaluated.On 2 out of 3 photos containing an inoculated plate, it is observed an isolated colony in the inhibition area near the a taxo disc but not touching it.On the containing plate inoculated with "sample" it is observed a spread colonies (marked) near the disc, and one of the border is touching it.Based on photo evaluation the colonies near or at the border of the disc cannot be confirmed as disc contamination.No corrective action is required based on information evaluated and satisfactory results obtained during the qc test.Complaint is not confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.
Event or Problem Description
It was reported that one bd bbl¿ taxo¿ a discs for differentiation of group a streptococci was contaminated.There was no patient impact.The following information was provided by the initial reporter: contamination noticed after inoculation no patient samples affected - "we were doing proficiency testing and an a/b plate." customer is not qualified to identify the contamination colony color is white.

• Brand Name: BD BBL¿ TAXO¿ A DISCS FOR DIFFERENTIATION OF GROUP A STREPTOCOCCI
• Common Device Name: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17152836
• Report Number: 2647876-2023-00040
• Device Sequence Number: 3929593
• Product Code: JTO
• UDI-Device Identifier: 00382902310426
• UDI-Public: 00382902310426
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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
• Operator of Device: Other
• Device Expiration Date: 07/31/2023
• Device Model Number: 231042
• Device Catalogue Number: 231042
• Device Lot Number: 2003421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown