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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 22.7L YEL AU 1103 NON-VENT; SHARPS CONTAINER
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BECTON DICKINSON SHARPS COLL 22.7L YEL AU 1103 NON-VENT; SHARPS CONTAINER Back to Search Results
Catalog Number 303509
Device Problem Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.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 in and the (b)(4) fda registration number has been used for the manufacture report number.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Medical device lot #: 9292924.Medical device expiration date: na.Device manufacture date: 2019-10-28.Medical device lot #: 8229939.Medical device expiration date: na.Device manufacture date: 2018-09-06.Medical device lot #: 9291911.Medical device expiration date: na.Device manufacture date: 2019-10-28.Medical device lot #: 3208910.Medical device expiration date: na.Device manufacture date: 2013-08-07.Medical device lot #: 8362932.Medical device expiration date: na.Device manufacture date: 2019-01-08.Medical device lot #: 8363918.Medical device expiration date: na.Device manufacture date: 2019-01-08.Medical device lot #: 9024942.Medical device expiration date: na.Device manufacture date: 2019-02-04.Medical device lot #: 8236912.Medical device expiration date: na.Device manufacture date: 2018-09-06.Medical device lot #: 9002925.Medical device expiration date: na.Device manufacture date: 2019-01-08.Medical device lot #: 7327934.Medical device expiration date: na.Device manufacture date: 2017-12-08.Medical device lot #: 0011943.Medical device expiration date: 2025-02-01.Device manufacture date: 2020-04-16.Medical device lot #: 9325936.Medical device expiration date: na.Device manufacture date: 2019-12-04.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 sharps coll 22.7l yel au 1103 non-vent lids were damaged.This occurred on 37 occasions.The following information was provided by the initial reporter: smashed lids.When the customer opened the carton they noticed some of the lids were smashed.They were unable to use the product.
 
Event Description
It was reported that sharps coll 22.7l yel au 1103 non-vent lids were damaged.This occurred on 37 occasions.The following information was provided by the initial reporter: smashed lids.When the customer opened the carton they noticed some of the lids were smashed.They were unable to use the product.
 
Manufacturer Narrative
H6: investigation summary: a sample representation was provided for the complaint.A dhr review was performed and showed there were no issues reported like lid broken ¿ damaged during the manufacturing process of the lots mentioned.A review of non-conforming material report (ncmr) was performed for this part for the past 12 months and no issues were reported for lid broken ¿ damaged for the same part number.The broken corners were observed on sample provided.As part of this investigation there is not enough information provided like pictures of packaging used to send material to the end user, in accordance with available information.There was a quality alert posted within the manufacturing plant to make all employees aware of this failure and how to spot ones like it in future inspections.Potential root causes are incorrect handling, partial sells, and inadequate packaging by distributor.Bd will continue to monitor for any trends.
 
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Brand Name
SHARPS COLL 22.7L YEL AU 1103 NON-VENT
Type of Device
SHARPS CONTAINER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11673756
MDR Text Key247037742
Report Number2243072-2021-01154
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 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number303509
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2021
Date Manufacturer Received07/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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