MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS; SYSTEM, BLOOD CULTURING

Model Number	442265
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd bactec¿ lytic/10 anaerobic/f culture vials produced 37 false positives in drawer a, and 27 false positives in drawer d an hour after being turned off for 10 minutes.There was no indication of confirmatory testing, or that results were reported to clinicians.There was also no report of patient impact.The following information was provided by the initial reporter: "false positives an hour after turning back on after rack reseated in bottom stack all were anaerobic media type.37 false positives in drawer a instrument t10044.27 false positives in drawer d instrument fb8823"."instruments checked out normal problems found but have discovered the anaerobic media type has possibly been the culprit triggered by drop in temp while instrument off for 10 minutes".
Additional Manufacturer Narrative
The reported lot# 1270320 was not found for the reported catalog# 442265.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
Correction: after further review, this complaint was found to be not reportable.Bubbles would not contribute to the issue being reported, (a large number of false positives within a short period of time), and bubbles should not have an effect on performance.False positives are captured under mfr# 1119779-2022-00150.This complaint will be cancelled.
Event or Problem Description
It was reported that the bd bactec¿ lytic/10 anaerobic/f culture vials produced 37 false positives in drawer a, and 27 false positives in drawer d an hour after being turned off for 10 minutes.There was no indication of confirmatory testing, or that results were reported to clinicians.There was also no report of patient impact.The following information was provided by the initial reporter: "false positives an hour after turning back on after rack reseated in bottom stack all were anaerobic media type 37 false positives in drawer a instrument t10044 27 false positives in drawer d instrument fb8823" "instruments checked out normal problems found but have discovered the anaerobic media type has possibly been the culprit triggered by drop in temp while instrument off for 10 minutes".

• Brand Name: BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS
• Common Device Name: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13562065
• Report Number: 2647876-2022-00022
• Device Sequence Number: 17257401
• Product Code: MDB
• UDI-Device Identifier: 00382904422653
• UDI-Public: 00382904422653
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K954925
• 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 Model Number: 442265
• Device Catalogue Number: 442265
• Device Lot Number: SEE SECTION H10
• 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: 01/20/2022
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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