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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 2ML BD SYRINGE WITH 23 G X 1 IN. NEEDLE SEE H.10

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BECTON DICKINSON, S.A. 2ML BD SYRINGE WITH 23 G X 1 IN. NEEDLE SEE H.10 Back to Search Results
Catalog Number 301940
Device Problem Fungus in Device Environment (2316)
Patient Problem No Patient Involvement (2645)
Event Date 06/02/2020
Event Type  malfunction  
Manufacturer Narrative
There were multiple medical device types reported to be involved. The information for the additional device type is as follows: medical device type: fmf/fmi. Common device name: piston syringe/hypodermic single lumen needle. 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 prior to use when opening packaging a substance suspected of mold was discovered at the bottom of the package with a 2ml bd syringe¿ with 23 g x 1 ¼ in. Needle. The following information was provided by the initial reporter, translated from (b)(6) to english: the equipment department found that when opening the middle package, there was a substance suspected of mildew in the paper seal layer of some rows of syringes. It was found that the bottom of the middle packaging carton was damp. This time there are a large number of problematic items.
 
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Brand Name2ML BD SYRINGE WITH 23 G X 1 IN. NEEDLE
Type of DeviceSEE H.10
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10179286
MDR Text Key198784257
Report Number3002682307-2020-00191
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301940
Device Lot Number1906102
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/22/2020 Patient Sequence Number: 1
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