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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD BBL¿ CULTURESWAB¿, STERILE, SINGLE SWAB (100 PKG.); CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE
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BECTON DICKINSON BD BBL¿ CULTURESWAB¿, STERILE, SINGLE SWAB (100 PKG.); CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE Back to Search Results
Catalog Number 220115
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2021
Event Type  malfunction  
Event Description
It was reported that while using bd bbl¿ cultureswab¿, sterile, single swab (100 pkg.) a splash of reagent was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: "possible defect in the tube which is resulting in leaking is not visible prior to addition of the liquid media.".
 
Manufacturer Narrative
Oem manufacture: the manufacturing location for this product is dc us four oaks.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 while using bd bbl¿ cultureswab¿, sterile, single swab (100 pkg.) a splash of reagent was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: "possible defect in the tube which is resulting in leaking is not visible prior to addition of the liquid media.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 27-dec-2021.H.6.Investigation: this statement serves to summarize findings on the recent complaint on product 220115 (cultureswab sterile single swab), lot number 2013234, where it was observed that the tube had a hole in it.Event description: " damage to the plastic shaft containing the swabs were identified when processed in the lab.2 holes visible.Processing the swab requires liquid media to be added to the dry swab when received in a biological safety cabinet which squirts out of the plastic shaft containing the swab and media during processing.This has resulted in an incident whereby liquid media has squirted on to s staff members coat¿ 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: a review of the device history record does not indicate any manufacturing issues.Sample analysis: the returns were inspected, and no holes were found.The retention samples did not exhibit any defects.Evaluations results: based on the investigation, the return samples were satisfactory and did not have the noted defect.There is no systemic failure in the manufacturing process.As no deviations were observed in the investigation and the retention samples were satisfactory, no corrective or preventive actions are indicated at this time.Investigation conclusion: based on the evaluation of the investigation, the complaint was not confirmed on the returns.This product is a dry swab with no media in it.Additionally, the addition of media to this tube is not covered in the product insert and any processing of the swab not covered in the insert needs to be validated by the customer.No further actions will be taken as no confirmed trend has been identified.Bd will continue to monitor for trending.
 
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Brand Name
BD BBL¿ CULTURESWAB¿, STERILE, SINGLE SWAB (100 PKG.)
Type of Device
CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13029122
MDR Text Key283822085
Report Number2243072-2021-02934
Device Sequence Number1
Product Code KDT
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
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 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number220115
Device Lot Number2013234
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2020
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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