MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ STAPHYLOSLIDE¿ LATEX TEST KIT, 100 TESTS; ANTISERA, FLUORESCENT, ALL TYPES, STAPHYLOSLIDE SPP.

Model Number	240915
Medical Device Problem Codes	Contamination (1120); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
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.
Event or Problem Description
It was reported that while using bd bbl¿ staphyloslide¿ latex test kit, 100 tests a false positive result was obtained and contamination was observed by the laboratory personnel.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: "it would already become positive without samples and inside it would be somewhat flocculated, nothing could be read.".
Additional Manufacturer Narrative
Investigation summary: this statement serves to summarize findings on the recent complaint 3007316 on product 240915 (kit staphyloslide latex 100 test) lot number c18976, where it was observed that the test latex appeared to have agglutination without any test sample.Complaint history review: a review of past complaints on this product over the past 12 months does not indicate a trend on this issue.Device history record review: the review of the device history record did not indicate any discrepancies.All release testing was satisfactory and no deviations were noted.Sample analysis: no photos or returns were available.An inspection of the retention samples did not reproduce the noted defect.Evaluations results: based on the investigation, no defect was observed.There is no systemic failure in the manufacturing process and the retention samples were satisfactory.As no deviations were observed in the investigation, no corrective or preventive actions are indicated at this time.Bd will continue to monitor for trending.Investigation conclusion: based on the evaluation of the investigation, the complaint was not confirmed.No further actions will be taken as no confirmed trend has been identified.A definite root cause could not be determined.H3 other text : see h10.
Event or Problem Description
It was reported that while using bd bbl¿ staphyloslide¿ latex test kit, 100 tests a false positive result was obtained and contamination was observed by the laboratory personnel.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: "it would already become positive without samples and inside it would be somewhat flocculated, nothing could be read.".

• Brand Name: BD BBL¿ STAPHYLOSLIDE¿ LATEX TEST KIT, 100 TESTS
• Common Device Name: ANTISERA, FLUORESCENT, ALL TYPES, STAPHYLOSLIDE SPP.
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12084377
• Report Number: 1119779-2021-01075
• Device Sequence Number: 11168363
• Product Code: GTN
• UDI-Device Identifier: 00382902409151
• UDI-Public: 00382902409151
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• 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): 01/24/2022

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: 04/30/2022
• Device Model Number: 240915
• Device Catalogue Number: 240915
• Device Lot Number: C18976
• 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: 06/01/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• 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