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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 13.2L YELLOW AU; SHARPS CONTAINER
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BECTON DICKINSON SHARPS COLL 13.2L YELLOW AU; SHARPS CONTAINER Back to Search Results
Catalog Number 303507
Device Problem Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Patient Involvement (2645)
Event Date 09/01/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturing location for this product is flextronics.This site is an oem manufacturing site.(b)(4).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.(b)(4).
 
Event Description
It was reported that sharps coll 13.2l yellow au lid was damaged.This was discovered before use.The following information was provided by the initial reporter: lid on sharps container able to be detached with minimal force.When testing for effective closure we noticed that the front right corner could not be closed securely.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2020-09-29 h6: investigation summary according with this investigation a review of customer complaint records was performed; according with the cc¿s records, no complaints were received through the last twelve months for the same part number and issue.Also, as part of this investigation the evidence provided by the customer was evaluated, the following can be seen: 1.The lid and bottom are assembled (in three padlocks and one lifted by the end user).2.The lot number 9206949 was confirmed manufactured by flex.3.The part number 303507 was confirmed like affected lot.4.No visually damages can be seen on the lid and base.Regarding to issue reported under this complaint (sharps collector assembled and lid comes off when pushed on corners), this failure mode could be caused by different conditions however, the pull test performed by the end user is not feature evaluated within the manufacturing process, therefore, there is not a test method to confirm if the test made by the end user is properly carried out.Due to the current specification doesn¿t required a pull test to separate the top from the base, (it only requires the force to perform the assembly) the correct condition to evaluate the assembly is through the measurements on the parts (base and lid) in order to make sure that they are in compliance with the drawing specifications.Additionally, the method used by the hospital to separate the parts will be needed to determine if the method used is correct in accordance to product design/use.According to the dhr review process; the result showed there were no issues reported like lid 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 lid broken for the same part number throughout the last twelve months.Based on this investigation this issue cannot be determined as related to the manufacturing process because there are different conditions that could cause this failure as deformation on the product caused by incorrect handling/storage.As part of the following up on this complaint some samples were measured on the area with interaction between the assembly (top and base), the base was found within minimum specification on the padlocks because of this an improvement action (padlocks were increased to maximum specification) was implemented in order to get a better retention force between assembly, the retention force was improved from 10lbs to 17lbs.If additional information (test method used by end user) that helps to find the root cause can be provided, then a new investigation path will be open to address this issue.All the complaint information was captured for tracking and trending purposes.H3 other text : see h.10.
 
Event Description
It was reported that sharps coll 13.2l yellow au lid was damaged.This was discovered before use.The following information was provided by the initial reporter: lid on sharps container able to be detached with minimal force.When testing for effective closure we noticed that the front right corner could not be closed securely.
 
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Brand Name
SHARPS COLL 13.2L YELLOW AU
Type of Device
SHARPS CONTAINER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key10570941
MDR Text Key214808169
Report Number2243072-2020-01486
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 10/23/2020
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 Number303507
Device Lot Number9206949
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2020
Initial Date Manufacturer Received 09/01/2020
Initial Date FDA Received09/22/2020
Supplement Dates Manufacturer Received09/01/2020
Supplement Dates FDA Received10/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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