MAUDE Adverse Event Report: LEE LABORATORIES, INC. BD BBL¿ VDRL ANTIGEN; DIAGNOSTIC STAINS & REAGENTS

Model 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	01/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd bbl¿ vdrl antigen there was a performance issue.The ph was out of range.There was no report of adverse patient impact.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: "the ph of vdrl buffered saline is out of range.The buffered saline seems to only be reaching a ph of ~5.3-5.7.Customer opened several kits, used current as well as a brand new ph meter to test the ph and none of them reached the required 6.0 +/- 1 reading." customer has confirmed not deviating from the package insert.Customer checked the ph with ph paper in addition to our usual method of the extech.The ph paper results matched the extech.The probe is calibrated before each use.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-02-23 h6: investigation summary to investigate the complaint on vdrl antigen kit 240765 batch 1217554, two retained bottles and the returned bottle of the buffered saline included in the complaint lot, batch 0198673, were tested for ph.This testing was performed using a ph meter calibrated with a 3-point calibration that included ph 4, 7, and 10 buffers.In addition to calibration, a ph 6 buffer was tested to ensure the accuracy of the ph meter.The electrode used for the investigation testing 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.After calibration and check of the ph 6 buffer, a sample of each bottle of buffered saline was tested and results were as follows: - retained bottle #1, ph 6.04 at 25.4 °c and retained bottle #2, ph 6.04 at 24.8 °c, which were both within the acceptable range of 5.9 ¿ 6.1.- vdrl buffered saline in returned kit, ph 6.01 at 25.1 °c.The complaint could not be confirmed based on these results.H3 other text : see h10.
Event or Problem Description
It was reported when using the bd bbl¿ vdrl antigen there was a performance issue.The ph was out of range.There was no report of adverse patient impact.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: "the ph of vdrl buffered saline is out of range.The buffered saline seems to only be reaching a ph of ~5.3-5.7.Customer opened several kits, used current as well as a brand new ph meter to test the ph and none of them reached the required 6.0 +/- 1 reading." customer has confirmed not deviating from the package insert.Customer checked the ph with ph paper in addition to our usual method of the extech.The ph paper results matched the extech.The probe is calibrated before each use.".

• Brand Name: BD BBL¿ VDRL ANTIGEN
• Common Device Name: DIAGNOSTIC STAINS & REAGENTS
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13641133
• Report Number: 1025402-2022-00003
• Device Sequence Number: 16677970
• Product Code: GMQ
• UDI-Device Identifier: 00382902407652
• UDI-Public: 00382902407652
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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 Expiration Date: 07/25/2023
• Device Model Number: 240765
• Device Catalogue Number: 240765
• Device Lot Number: 1217554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2021
• 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