MAUDE Adverse Event Report: LEE LABORATORIES, INC. BD BBL¿ VDRL ANTIGEN; ANTIGENS, NONTREPONEMAL, ALL

Catalog Number	240765
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	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd bbl¿ vdrl antigen the saline solution ph is inconsistent between several testing methods, ph test strips, ph meter/probe, and multistick.No health impact or consequence reported.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: to investigate the complaint on catalog 240765, lot 2227252, the buffered saline included in the retained kit of the complaint lot was tested for ph.A return sample was not received.This testing was performed using a calibrated ph meter with a three - point calibration that included ph (b)(4) buffers.After calibration, the retained sample of the buffered saline was tested, and results were as follows: - retained bottle yielded 5.99 at 24.6°c, which is within the acceptable range of 5.95 ¿ 6.05 at 25°c.The complaint was not confirmed based on the ph result obtained.The electrode used with the ph meter is a ph / atc electrode.The internal test procedure for this product requires that all calibration buffers and test samples are warmed to 25 ± 1°c prior to use / test.Possible sources of error for the customer include ph sample was tested at a temperature slightly different than the recommended temperature for buffered saline, or contamination of the buffered saline samples.The batch history record for the complaint lot was reviewed and found satisfactory; no quality notifications were issued for this lot.Complaints for the product line were reviewed.There have been (b)(4) complaints received on the catalog number; there have been no other complaints received for the complaint lot; bd will continue to monitor closely for trends.No corrective action is needed at this time.
Event or Problem Description
It was reported while using the bd bbl¿ vdrl antigen the saline solution ph is inconsistent between several testing methods, ph test strips, ph meter/probe, and multistick.No health impact or consequence reported.

• Brand Name: BD BBL¿ VDRL ANTIGEN
• Common Device Name: ANTIGENS, NONTREPONEMAL, ALL
• Manufacturer (Section D): LEE LABORATORIES, INC.; 1475 athens highway; grayson GA 30017
• Manufacturer (Section G): LEE LABORATORIES, INC.; 1475 athens highway; grayson GA 30017
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19824447
• Report Number: 1025402-2024-00009
• Device Sequence Number: 8684635
• Product Code: GMQ
• UDI-Device Identifier: 00382902407652
• UDI-Public: (01)00382902407652
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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: 05/24/2025
• Device Catalogue Number: 240765
• Device Lot Number: 3103242
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2023
• 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