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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CANADA 3.0L YELLOW; SHARPS CONTAINER
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BECTON DICKINSON SHARPS COLL CANADA 3.0L YELLOW; SHARPS CONTAINER Back to Search Results
Catalog Number 300450
Device Problem Difficult to Open or Close (2921)
Patient Problem No Patient Involvement (2645)
Event Date 09/22/2020
Event Type  malfunction  
Manufacturer Narrative
Oem manufacture: 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.The date received by manufacturer has been used for this field.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.(b)(4).
 
Event Description
It was reported that 18 sharps coll canada 3.0l yellow experienced no lids.The following information was provided by the initial reporter: material no.: 300450, batch no.: 0062912.It was reported that the collectors were recieved without lids.
 
Event Description
It was reported that 18 sharps coll canada 3.0l yellow experienced no lids.The following information was provided by the initial reporter: material no.: 300450, batch no.: 0062912.It was reported that the collectors were "received" without lids.
 
Manufacturer Narrative
H6: investigation summary: no actual product or photo representation was provided.A review of the device history record (dhr) for the reported lot was performed and there were no issues found for missing lids during the manufacturing process of the reported lot.A review of non-conforming material report (ncmr) was performed for the last twelve months and did not identify any nonconformance.As corrective action a weighing system has already been implemented for this container manufacturing process to ensure the correct quantity of pieces per box before shipping.The root cause is unknown.The issue most likely occurred during fulfillment when repackaged for distribution.This complaint may have occurred from partial sales sold by a distributor.Additional information is needed about the handling and storage by the distributor facility to rule out that the issue was not due to incorrect handling or a partial sale.Based on these findings, our investigation is inconclusive.Evidence of original packaging is required.Bd will continue to monitor for any trends.
 
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Brand Name
SHARPS COLL CANADA 3.0L YELLOW
Type of Device
SHARPS CONTAINER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key10891787
MDR Text Key252278032
Report Number2243072-2020-01917
Device Sequence Number1
Product Code MMK
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300450
Device Lot Number0062912
Was Device Available for Evaluation? No
Date Manufacturer Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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