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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL MEXICO 22.7L RED; SHARPS CONTAINER
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BECTON DICKINSON SHARPS COLL MEXICO 22.7L RED; SHARPS CONTAINER Back to Search Results
Catalog Number 300182
Device Problem Device Misassembled During Manufacturing /Shipping (2912)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.Initial reporter additional phone#: (b)(6).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 mexico 22.7l red had a broken lid.The following information was provided by the initial reporter: when filling an order, a broken lid of material 17-300182 sharps collector 22.7 l.
 
Manufacturer Narrative
H6: investigation summary 2 photo representation were provided for the complaint.A dhr review was performed and showed there were no issues reported like lid broken during the manufacturing process of the lot number 0168935.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 for the same part number.The photos clearly show broken corner of lid but evidence of the packaging used is needed to determine the root cause.Therefore, due to lack of evidence it can¿t be confirmed this nonconformance as a failure mode related to a manufacturing process, because this kind of damages could be generated due to different variables like transit damaged, inadequate packaging to send the product to the end user.Root cause is unknown but there are multiple possible issues.The possible root causes: non-controlled method to ship partial boxes to end user, product damaged during the shipment or distribution (non-suitable packing), or incorrect packaging process at the time to perform partial sales.The controls were verified within the manufacturing process and confirmed as capable to detect lid damaged.H3 other text : see h10.
 
Event Description
It was reported that sharps coll mexico 22.7l red had a broken lid.The following information was provided by the initial reporter: when filling an order, a broken lid of material 17-300182 sharps collector 22.7 l.
 
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Brand Name
SHARPS COLL MEXICO 22.7L RED
Type of Device
SHARPS CONTAINER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11371020
MDR Text Key233285311
Report Number2243072-2021-00588
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 03/24/2021
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 Number300182
Device Lot Number0168935
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/28/2021
Initial Date FDA Received02/24/2021
Supplement Dates Manufacturer Received03/24/2021
Supplement Dates FDA Received04/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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