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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CULTURESWAB¿ PLUS AMIES GEL WITHOUT CHARCOAL, DOUBLE SWAB; TRANSPORT CULTURE MEDIUM
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BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CULTURESWAB¿ PLUS AMIES GEL WITHOUT CHARCOAL, DOUBLE SWAB; TRANSPORT CULTURE MEDIUM Back to Search Results
Catalog Number 220117
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2022
Event Type  malfunction  
Event Description
It was reported that bd bbl¿ cultureswab¿ plus amies gel without charcoal, double swab was found to have biologicals artifacts in the media.This event occurred 2 times.No confirmatory testing was done.No results were reported to clinician or patients.The following information was provided by the initial reporter: "customer reporting what appears to be artifacts in the gel of the cultureswab catalog# 220117, lot# 211031600.The customer states they look like yeast on the gram stain but are smaller.Steps taken with customer/troubleshooting: customer confirmed that the cultures came back negative for yeast on the patient samples.An un-inoculated swab was gram-stained and cultured and it also had the small yeast-like appearing artifacts which likewise did not grow on the culture.".
 
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 bd bbl¿ cultureswab¿ plus amies gel without charcoal, double swab was found to have biologicals artifacts in the media.This event occurred 2 times.No confirmatory testing was done.No results were reported to clinician or patients.The following information was provided by the initial reporter: "customer reporting what appears to be artifacts in the gel of the cultureswab catalog# 220117, lot# 211031600.The customer states they look like yeast on the gram stain but are smaller.Steps taken with customer/troubleshooting: customer confirmed that the cultures came back negative for yeast on the patient samples.An un-inoculated swab was gram-stained and cultured and it also had the small yeast-like appearing artifacts which likewise did not grow on the culture.".
 
Manufacturer Narrative
H.6: device evaluation: the customer complaint of artifacts in the gel of cat.220117, lot 211031600 was not confirmed.The returned samples from the customer were reviewed and no artifacts were observed.An investigation of the retain samples and the device history record did not show any defects.A review of past complaints for this product does not indicate a trend for this issue.No further action will be taken as this is an isolated incident.Bd quality assurance will continue to monitor for trending.
 
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Brand Name
BD BBL¿ CULTURESWAB¿ PLUS AMIES GEL WITHOUT CHARCOAL, DOUBLE SWAB
Type of Device
TRANSPORT CULTURE MEDIUM
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 Key13766332
MDR Text Key291510801
Report Number1119779-2022-00436
Device Sequence Number1
Product Code MMP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972448
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2023
Device Catalogue Number220117
Device Lot Number211031600
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/26/2021
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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