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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL MX 1.4L RED; SHARPS COLLECTOR
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BECTON DICKINSON SHARPS COLL MX 1.4L RED; SHARPS COLLECTOR Back to Search Results
Catalog Number 300279
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/11/2020
Event Type  malfunction  
Manufacturer Narrative
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.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the sharps coll mx 1.4l red experienced a missing label for the fill line.The following information was provided by the initial reporter: without label for marking the input.The label missing is the one designed to identify the dates of beginning and replacement of the product.
 
Manufacturer Narrative
H.6.Investigation: photos received for investigation, in addition to the individual label analyzed above, the collective label is placed at the end of the process (corrugated box).This label does not contain fields to place the identification of the start and replacement date of the input mentioned by the customer.Based on the research carried out, it can be concluded that the label shown in the photograph sent by the client meets the specifications.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
 
Event Description
It was reported that the sharps coll mx 1.4l red experienced a missing label for the fill line.The following information was provided by the initial reporter: without label for marking the input.The label missing is the one designed to identify the dates of beginning and replacement of the product.
 
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Brand Name
SHARPS COLL MX 1.4L RED
Type of Device
SHARPS COLLECTOR
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11143910
MDR Text Key227523864
Report Number2243072-2021-00071
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 distributor,foreign,other
Type of Report Initial,Followup
Report Date 02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number300279
Device Lot Number20D07
Was Device Available for Evaluation? No
Date Manufacturer Received02/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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