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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 11L NEXT GEN YELLOW AU; SHARPS CONTAINER
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BECTON DICKINSON SHARPS COLL 11L NEXT GEN YELLOW AU; SHARPS CONTAINER Back to Search Results
Catalog Number 301274
Device Problem Device Markings/Labelling Problem (2911)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2021
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 11l next gen yellow au had incorrect label information on 8 occasions.The following information was provided by the initial reporter: 5.1ll label 301272 placed on 11.3 l container.
 
Event Description
It was reported that sharps coll 11l next gen yellow au had incorrect label information on 8 occasions.The following information was provided by the initial reporter: 5.1ll label 301272 placed on 11.3 l container.
 
Manufacturer Narrative
Investigation summary: a photo but no sample representation was provided for the complaint.A dhr review was performed and showed there were no issues reported like labeling concerns during the manufacturing process of the lot number 0130935.A review of non-conforming material report (ncmr) was performed for this part for the past 12 months and no issues were reported for labeling concerns for the same part number.According to this investigation this is a known failure mode related to a manufacturing process because it was reported in previous complaints record (b)(4), due to this complaints a capa record (b)(4).Was opened to implement a software update to mitigate any errors or duplicates in the base labels, the software was implemented on (b)(6) 2020, however, based in the manufacturing date of the lot number (0130935) reported in the complaint it was confirmed that the product was manufactured before a corrective actions implementation.Root cause found to be an omission error (before the corrective action implementation the in-house printing process was being performed through manual inputs).
 
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Brand Name
SHARPS COLL 11L NEXT GEN YELLOW AU
Type of Device
SHARPS CONTAINER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11341027
MDR Text Key232559609
Report Number2243072-2021-00346
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 03/02/2021
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 Number301274
Device Lot Number0130935
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/21/2021
Initial Date FDA Received02/17/2021
Supplement Dates Manufacturer Received03/02/2021
Supplement Dates FDA Received03/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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