MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CRYSTAL¿ GRAM-POSITIVE ID SYSTEM; GRAM POSITIVE IDENTIFICATION PANEL

Model Number	245240
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd bbl¿ crystal¿ gram-positive id system experienced discrepant label information.The following information was provided by the initial reporter: batch difference.They delivered this material with a certain batch, but when the client uncovered the box, the material inside had another batch that did not appear on the page.
Additional Manufacturer Narrative
Medical device lot #: an invalid lot # of 1309615 was provided.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
The following fields were updated due to corrected information: d.4.Medical device lot #: 1309615.H.6.Investigation: this complaint is for discrepant batch numbers and expiration dates when using kit crystal gram-positive id (245240) batch number 1309615.Photos were provided for investigation.The photos show the various kit products with the corresponding batch numbers and expiration dates.The products in the kit will and should have different batch numbers and expiration dates.The expiration date chosen for the certificate of analysis is the shortest or closest expiration date of all the products in the kit.This complaint is not confirmed.A review of quality notifications revealed no quality notifications generated for the complaint batch.A review of complaints revealed no additional complaints on this batch.Complaint trending identified no trends related to this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.
Event or Problem Description
It was reported that the bd bbl¿ crystal¿ gram-positive id system experienced discrepant label information.The following information was provided by the initial reporter: batch difference.They delivered this material with a certain batch, but when the client uncovered the box, the material inside had another batch that did not appear on the page.

• Brand Name: BD BBL¿ CRYSTAL¿ GRAM-POSITIVE ID SYSTEM
• Common Device Name: GRAM POSITIVE IDENTIFICATION PANEL
• 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: 13536918
• Report Number: 1119779-2022-00241
• Device Sequence Number: 14510053
• Product Code: LQL
• UDI-Device Identifier: 30382902452400
• UDI-Public: 30382902452400
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K961968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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
• Operator of Device: Other
• Device Model Number: 245240
• Device Catalogue Number: 245240
• Device Lot Number: 1309615
• 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: 01/20/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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