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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SHARPS CONTAINER
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BECTON DICKINSON UNSPECIFIED BD SHARPS CONTAINER Back to Search Results
Catalog Number 305160
Device Problem Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2021
Event Type  malfunction  
Manufacturer Narrative
The manufacturing location for this product is flextronics.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.Medical device expiration date: na.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 unspecified bd¿ sharps container was received with broken lids.This occurred on 12 occasions.The following information was provided by the initial reporter: it was reported by the facility representative that they have received broken lids.
 
Event Description
It was reported that unspecified bd¿ sharps container was received with broken lids.This occurred on 12 occasions.The following information was provided by the initial reporter: it was reported by the facility representative that they have received broken lids.
 
Manufacturer Narrative
H6: investigation summary: the customer provided 12 samples with the complaint of broken lids.The sharps containers were received without any lids so the complaint was investigated by the supplier as it was received.According to the dhr review process, the result showed there were no issues reported like lid broken/damaged during the manufacturing process of the lot number 0303954 reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like lid broken/damaged for the same part number throughout the last twelve months.The supplier investigated this complaint as a missing lids issue due to what was received and were unable to determine root cause.H3 other text : see h10.
 
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Brand Name
UNSPECIFIED BD SHARPS CONTAINER
Type of Device
SHARPS CONTAINER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11963342
MDR Text Key272280392
Report Number2243072-2021-01638
Device Sequence Number1
Product Code MMK
UDI-Device Identifier00382903051601
UDI-Public00382903051601
Combination Product (y/n)N
PMA/PMN Number
K112774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 09/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305160
Device Lot Number0303954
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2021
Date Manufacturer Received09/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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