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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CULTURESWAB¿ LIQUID STUART, DOUBLE SWAB; CULTURE MEDIA, NON-PROPAGATING TRANSPORT
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BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CULTURESWAB¿ LIQUID STUART, DOUBLE SWAB; CULTURE MEDIA, NON-PROPAGATING TRANSPORT Back to Search Results
Catalog Number 220109
Device Problems Contamination (1120); False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2021
Event Type  malfunction  
Event Description
It was reported that during use with the bd bbl¿ cultureswab¿ liquid stuart, double swab, 3 patient specimens received false positive results due to possible contamination of the swabs.There was no report of patient impact.The following information was provided by the initial reporter: per medwatch reports, the swabs were used for abscess collection for all 3 separate patients.Customer reports three cultures contaminated with bacteria while using cat 220109 lot 210464700.End user reports 3 patient cultures that have growth.One culture had finegoldia magna and the two other cultures had finegoldia magna and actinomyces neuii.End user alleges the swabs are introducing the contamination.
 
Manufacturer Narrative
Oem manufacturing site: in this mdr, bd ds headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.The initial reporter also notified the fda in dec.2021, medwatch uf/importer report (b)(4).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H.6 investigation summary: the customer complaint of three cultures contaminated with bacteria while using cat.220109, lot 210464700 was not confirmed.The retention samples from cat.220109, lot 210464700 did not exhibit any defects.A review of the device history record did not indicate any discrepancies.All release testing was satisfactory, and no deviations were noted.Based on the investigation, no defect was observed.No corrective or preventive actions are indicated at this time.Bd quality assurance will continue to monitor for trending.
 
Event Description
It was reported that during use with the bd bbl¿ cultureswab¿ liquid stuart, double swab, 3 patient specimens received false positive results due to possible contamination of the swabs.There was no report of patient impact.The following information was provided by the initial reporter: per medwatch reports, the swabs were used for abscess collection for all 3 separate patients.Customer reports three cultures contaminated with bacteria while using cat 220109 lot 210464700.End user reports 3 patient cultures that have growth.One culture had finegoldia magna and the two other cultures had finegoldia magna and actinomyces neuii.End user alleges the swabs are introducing the contamination.
 
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Brand Name
BD BBL¿ CULTURESWAB¿ LIQUID STUART, DOUBLE SWAB
Type of Device
CULTURE MEDIA, NON-PROPAGATING TRANSPORT
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 Key13841043
MDR Text Key292077764
Report Number1119779-2022-00452
Device Sequence Number1
Product Code JSM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K946283
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2022
Device Catalogue Number220109
Device Lot Number210464700
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/04/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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