MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ VDRL ANTIGEN; ANTIGENS, NONTREPONEMAL, ALL

Model Number	240765
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
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.(b)(6).
Event or Problem Description
It was reported that bd bbl¿ vdrl antigen false negative occurred.The following information was provided by the initial reporter: customer reported 1).Cap survey "ga"; (b)(6) 2022; sample #g-02 was "reactive" while was supposed to be a neg.Attached survey says g-02 was non reactive and the intended report is reactive.Hazard, injury or erroneous results details which assays or tests are exhibiting issues? 240765.Are the values of the assays available? yes.Analyzer name & model #n/a.How many units (tubes) affected? 1.What is the frequency or occurrence rate (1 day, % of tubes affected, patients involved, how many tests per day etc.) pt.What was method of draw? ¿ straight needle ¿ wingset ¿ syringe ¿ line ¿ unsure/other (please list) pt is tube filled to stated volume? unknown.What was order of draw? n/a.How many times was the tube inverted? unknown.How were tubes transported? (pneumatic system, carrier, etc.) n/a.How long after collection were tubes processed? n/a.
Event or Problem Description
It was reported that bd bbl¿ vdrl antigen false negative occurred.The following information was provided by the initial reporter: customer reported 1).Cap survey "ga"; may 16, 2022; sample #g-02 was "reactive" while was supposed to be a neg.Attached survey says g-02 was non reactive and the intended report is reactive.Hazard, injury or erroneous results details which assays or tests are exhibiting issues? 240765.Are the values of the assays available? yes.Analyzer name & model #n/a.How many units (tubes) affected? 1.What is the frequency or occurrence rate (1 day, % of tubes affected, patients involved, how many tests per day etc.) pt.What was method of draw? straight needle wingset syringe line unsure/other (please list) pt.Is tube filled to stated volume? unknown.What was order of draw? n/a.How many times was the tube inverted? unknown.How were tubes transported? (pneumatic system, carrier, etc.) n/a.How long after collection were tubes processed? n/a.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2022-01376 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.

• Brand Name: BD BBL¿ VDRL ANTIGEN
• Common Device Name: ANTIGENS, NONTREPONEMAL, ALL
• 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: 15788447
• Report Number: 1119779-2022-01376
• Device Sequence Number: 20022281
• Product Code: GMQ
• UDI-Device Identifier: 00382902407652
• UDI-Public: 00382902407652
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/23/2022

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: 07/22/2024
• Device Model Number: 240765
• Device Catalogue Number: 240765
• Device Lot Number: 1308713
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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