MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) CONTROL SET FOR THE BD PROBETEC¿ (CT/GC) QX AMPLIFIED DNA ASSAYS; DNA REAGENTS, NEISSERIA

Catalog Number	441125
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to use, a control set for the bd probetec¿ (ct/gc) qx amplified dna assays had a label with missing barcode, lot number, and expiration date.
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
H.6.Investigation summary: bd integrated diagnostic systems initiated an investigation into missing barcode/label information on a ct/gc qx control tube (catalog # 441125, batch # 2262861).Bd investigation required review of the batch history records, review of retention materials from the customers reported reagent batch, review of customer returned photographic evidence and complaint trending review.The batch history records were reviewed and no discrepancies were noted.Retention materials from the customers reported reagent batch revealed properly labeled tubes.However, review of the customers returned photographic evidence revealed missing barcode/label information on a ct/gc qx control tube, thus confirming the customers report.No new complaint trends associated with missing barcode/label information on a ct/gc qx control tube occurred during (b)(6) 2024.Bd quality will continue to monitor for trends associated with missing barcode/label information on a ct/gc qx control tube.H3 other text : see h.10.
Event or Problem Description
It was reported that prior to use, a control set for the bd probetec¿ (ct/gc) qx amplified dna assays had a label with missing barcode, lot number, and expiration date.

• Brand Name: CONTROL SET FOR THE BD PROBETEC¿ (CT/GC) QX AMPLIFIED DNA ASSAYS
• Common Device Name: DNA REAGENTS, NEISSERIA
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18924754
• Report Number: 1119779-2024-00214
• Device Sequence Number: 18482782
• Product Code: LSL
• UDI-Device Identifier: 00382904411251
• UDI-Public: (01)00382904411251
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081825
• 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): 04/22/2024

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: 04/30/2024
• Device Catalogue Number: 441125
• Device Lot Number: 2262861
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• 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