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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SHARPS COLLECTOR
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BECTON DICKINSON UNSPECIFIED BD SHARPS COLLECTOR Back to Search Results
Catalog Number UNKNOWN
Device Problem Device Damaged Prior to Use (2284)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/30/2020
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) as been listed and (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that one unspecified bd¿ sharps collector was missing it's base, while another sharps collector had a cracked base.The following information was provided by the initial reporter: "2 sharps collectors that are broken.The bottom was missing on one of the containers and the bottom was cracked on the other container".
 
Event Description
It was reported that one unspecified bd¿ sharps collector was missing it's base, while another sharps collector had a cracked base.The following information was provided by the initial reporter: "2 sharps collectors that are broken.The bottom was missing on one of the containers and the bottom was cracked on the other container.".
 
Manufacturer Narrative
H6: investigation summary.It was reported that two sharp collectors were broken.On one of the containers, the bottom was missing and the other container was cracked at the bottom.From the pictures provided, it looks like the collectors were shipped in a different box other than the box originally provided by the manufacturer.This could be related to reshipping for partial sales by a distributor.It is likely that damage occurred during shipping.H3 other text : see h10.
 
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Brand Name
UNSPECIFIED BD SHARPS COLLECTOR
Type of Device
SHARPS COLLECTOR
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key10906602
MDR Text Key250323213
Report Number2243072-2020-01938
Device Sequence Number1
Product Code MMK
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/30/2020
Initial Date FDA Received11/25/2020
Supplement Dates Manufacturer Received03/12/2021
Supplement Dates FDA Received03/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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