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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 7.6L YEL AU NON-VENTED CAP; SHARPS COLLECTOR
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BECTON DICKINSON SHARPS COLL 7.6L YEL AU NON-VENTED CAP; SHARPS COLLECTOR Back to Search Results
Catalog Number 303506
Device Problem Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Oem manufacture: the manufacturing location for this product is (b)(4).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.
 
Event Description
It was reported that two sharps coll 7.6l yel au non-vented cap experienced a broken/damaged lid which was noted prior to use.The following information was provided by the initial reporter: sharps bin lids malformed.Sharps bins were received with 2 having incomplete lids.
 
Event Description
It was reported that two sharps coll 7.6l yel au non-vented cap experienced a broken/damaged lid which was noted prior to use.The following information was provided by the initial reporter: sharps bin lids malformed.Sharps bins were received with 2 having incomplete lids.
 
Manufacturer Narrative
H.6.Investigation summary: a sample photo was provided for investigation.According with this investigation a failure mode could not be confirmed, however the issue could possibly occur during the manufacturing process, but there is no evidence on pm (preventative maintenance) request where any issue with the lid mold was reported, dhr shows a normal manufacturing process without any issue for damage components.A non conformance was open but is not related to this complaint failure mode, for lid damage.Complaint evidence does show a nearly broken handle, however no additional photo evidence was received.The nearly broken handle could be caused by logistic handling (transportation, storage, distribution) but, since no additional picture could be provided for the complaint and no additional details were obtained, this failure mode could not be confirmed.The possible root causes for the reported issue are a molding issue during manufacturing, but more like product damage has occurred during shipment or distribution.H3 other text : see section h.10.
 
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Brand Name
SHARPS COLL 7.6L YEL AU NON-VENTED CAP
Type of Device
SHARPS COLLECTOR
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key9837487
MDR Text Key189780261
Report Number2243072-2020-00399
Device Sequence Number1
Product Code MMK
Combination Product (y/n)N
PMA/PMN Number
N/A
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 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number303506
Device Lot Number9G801
Was Device Available for Evaluation? No
Date Manufacturer Received02/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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