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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL SLIDE CLOSE 9 GAL RED KIT; SHARPS CONTAINER

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BECTON DICKINSON SHARPS COLL SLIDE CLOSE 9 GAL RED KIT; SHARPS CONTAINER Back to Search Results
Catalog Number 305118
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/21/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is hdq (b)(4).This site is an (b)(4)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: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that sharps coll slide close 9 gal red kit was damaged before use.The following information was provided by the initial reporter: the customer reported that the cart was damaged on arrival.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.4.Medical device lot #: 8324931 d.4.Medical device expiration date: na h.4.Device manufacture date: 11/19/2018 h.6.Investigation: according to the dhr review process; the result showed there were no issues reported like trolley damaged during the manufacturing process of the lot number reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like trolley damaged for the same part number throughout the last twelve months.Ccording with this investigation and the information provided from the customer (photos) it could be seen a nut damaged, a lot number (8324931) manufactured in 2018 and a box from flex (relabeled).For this reason, it can be concluded that there are many variables that could generate this failure mode as incorrect handling, not controlled repackaging process, not suitable packing, transportation damages, etc.Therefore, additional information (handling method used by the distributor, photos of transportation) is needed to determine the possible root cause that leads to this issue.
 
Event Description
It was reported that sharps coll slide close 9 gal red kit was damaged before use.The following information was provided by the initial reporter: the customer reported that the cart was damaged on arrival.
 
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Brand Name
SHARPS COLL SLIDE CLOSE 9 GAL RED KIT
Type of Device
SHARPS CONTAINER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key10857066
MDR Text Key265892738
Report Number2243072-2020-01849
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 foreign,other,user facility
Type of Report Initial,Followup
Report Date 12/21/2020
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 Number305118
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/21/2020
Initial Date FDA Received11/17/2020
Supplement Dates Manufacturer Received12/21/2020
Supplement Dates FDA Received01/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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