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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT SYRINGE S2; PERIPHERAL IV CATHETERS
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BECTON DICKINSON, S.A. BD DISCARDIT SYRINGE S2; PERIPHERAL IV CATHETERS Back to Search Results
Catalog Number 309110
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2024
Event Type  malfunction  
Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
 
Event Description
It was reported that bd discardit syringe s2 foreign matter in syringe.The following information was provided by the initial reporter: there were a lot of plastic particles in the syringe when the medication was drawn up.During use.
 
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Brand Name
BD DISCARDIT SYRINGE S2
Type of Device
PERIPHERAL IV CATHETERS
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
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key18741636
MDR Text Key336750364
Report Number3002682307-2024-00030
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/02/2024
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 Number309110
Device Lot Number2308149
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/30/2024
Initial Date FDA Received02/20/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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