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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL ASIA 13.2L YEL 1508 NON-VENT; SHARPS CONTAINER
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BECTON DICKINSON SHARPS COLL ASIA 13.2L YEL 1508 NON-VENT; SHARPS CONTAINER Back to Search Results
Catalog Number 300195
Device Problem Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2021
Event Type  malfunction  
Manufacturer Narrative
(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.
 
Event Description
It was reported that sharps coll asia 13.2l yel 1508 non-vent was cracked.This occurred on 3 occasions.The following information was provided by the initial reporter: received 3x 13l sharp container cover that is cracked.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-03-24.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 lot number 0141946.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.Potential root causes are incorrect handling, partial sells, and inadequate packaging by distributor.Bd will continue to monitor for any trends.
 
Event Description
It was reported that sharps coll asia 13.2l yel 1508 non-vent was cracked.This occurred on 3 occasions.The following information was provided by the initial reporter: received 3x 13l sharp container cover that is cracked.
 
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Brand Name
SHARPS COLL ASIA 13.2L YEL 1508 NON-VENT
Type of Device
SHARPS CONTAINER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11646272
MDR Text Key244920726
Report Number2243072-2021-01090
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 other,user facility
Type of Report Initial,Followup
Report Date 06/22/2021
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 Number300195
Device Lot Number141946
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2021
Initial Date Manufacturer Received 03/12/2021
Initial Date FDA Received04/09/2021
Supplement Dates Manufacturer Received06/22/2021
Supplement Dates FDA Received07/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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