MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR V FACTOR; DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

Model Number	231727
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that 60 bd bbl¿ taxo¿ differentiation discs for v factor during validation no growth occurred.The following information was provided by the initial reporter: no growth of haemophilus influenzae at the edge of 60 disc with the use of a cos + factor v medium during validation no growth , are testing now with other batch , tomorrow noon 11/1/23 12h i have to call the customer for results other batch.
Event or Problem Description
It was reported that 60 bd bbl¿ taxo¿ differentiation discs for v factor during validation no growth occurred.The following information was provided by the initial reporter: no growth of haemophilus influenzae at the edge of 60 disc with the use of a cos + factor v medium during validation no growth , are testing now with other batch , tomorrow noon 11/1/2023 12h i have to call the customer for results other batch.
Additional Manufacturer Narrative
H6 investigation summary: a complaint investigation due to no growth for taxo v factors catalog 231727 batch no.: 6924935 was performed on retention samples.Returned goods were not received from customer.The investigation required to test product for performance, 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.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.

• Brand Name: BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR V FACTOR
• Common Device Name: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 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: 16209274
• Report Number: 1119779-2023-00045
• Device Sequence Number: 20144143
• Product Code: JTO
• UDI-Device Identifier: 00382902317272
• UDI-Public: 00382902317272
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

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: 09/30/2023
• Device Model Number: 231727
• Device Catalogue Number: 231727
• Device Lot Number: 2056543
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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