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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLLECTOR; SHARPS CONTAINER
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BECTON DICKINSON BD¿ SHARPS COLLECTOR; SHARPS CONTAINER Back to Search Results
Catalog Number 300491
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/30/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 1225 bd¿ sharps collector lids had several holes in them.The following information was provided by the initial reporter: "when received by our warehouse, they found there're several "holes" on the cap, which never seen previously".
 
Manufacturer Narrative
Investigation summary: photos representation was provided for the complaint of package damaged / defective / other where customer found there're several "holes" on the cap.A device history record review for material # 300491and lot number 2047002 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2022.A review of the ncr was performed.Non-conformity: wrong cap placed on collector.Caps have holes (vents) in them and no handle which makes this an 8079912 cap.Requirement(s): collector must have the correct cap.Cap should not have holes (vents) in them and should have a handle attached to the cap.
 
Event Description
It was reported that 1225 bd¿ sharps collector lids had several holes in them.The following information was provided by the initial reporter: "when received by our warehouse, they found there're several "holes" on the cap, which never seen previously".
 
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Brand Name
BD¿ SHARPS COLLECTOR
Type of Device
SHARPS CONTAINER
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 Key14828240
MDR Text Key303256389
Report Number2243072-2022-00863
Device Sequence Number1
Product Code MMK
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
NA
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 07/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300491
Device Lot Number2047002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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