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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING

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BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING Back to Search Results
Model Number 442023
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2021
Event Type  malfunction  
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 Description
It was reported that a bd bactec¿ plus aerobic/f culture vials (plastic) produced false positive results. An erroneous result was reported to clinicians, but no patients were treated based on them, and there was no report of any other adverse patient impact. The following information was provided by the initial reporter: "customer reporting nonviable contamination leading to false positive report using 442023 - bactec plus aerob/f lot 1230635. " "4 vials flagged around 1 hour from entry due to sensor adhesion issues (case (b)(4)); vials were stained and cultured; 2 of 4 vials presented with gram positive bacilli on the gram stain; 0 of 4 vials had culture growth. 1 of 4 vials sent to phol for 16s pcr. " " were any erroneous results reported to the doctors? two erroneous results were reported in the gram stain "gram positive bacilli" (initially reported). This was corrected to "no organisms seen". If yes, were any patients treated based on erroneous results? no patients were treated based on erroneous results. If yes, did the erroneous treatment have any adverse impact to the patient(s)? n/a".
 
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Brand NameBD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
Type of DeviceSYSTEM, 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 Key13090946
MDR Text Key290444784
Report Number2647876-2021-00374
Device Sequence Number1
Product Code MDB
UDI-Device Identifier00382904420239
UDI-Public00382904420239
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K113558
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2022
Device Model Number442023
Device Catalogue Number442023
Device Lot Number1230635
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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