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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ 20 ML SYRINGE WITH NEEDLE; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD¿ 20 ML SYRINGE WITH NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 301948
Device Problem Fungus in Device Environment (2316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2021
Event Type  malfunction  
Event Description
It was reported that 80 bd¿ 20 ml syringes with needle had mold presence.The following information was provided by the initial reporter: "when we opened the package, it found that there were mildew spots in one box".
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
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 80 bd¿ 20 ml syringes with needle had mold presence.The following information was provided by the initial reporter: "when we opened the package, it found that there were mildew spots in one box".
 
Event Description
It was reported that 80 bd¿ 20 ml syringes with needle had mold presence.The following information was provided by the initial reporter: "when we opened the package, it found that there were mildew spots in one box.".
 
Manufacturer Narrative
H.6.Investigation: a device history record review was completed for provided material number 301948 and lot number 2105131.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, retained samples were obtained for further evaluation by our quality engineer team.Through examination of the retained samples, no signs of defect could be observed.Based on the limited investigation results, an exact cause could not be determined for the reported incident.
 
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Brand Name
BD¿ 20 ML SYRINGE WITH NEEDLE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP  22520
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP   22520
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13192269
MDR Text Key285614488
Report Number3002682307-2021-00675
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 Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301948
Device Lot Number2105131
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/04/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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