• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT¿ II PISTON SYRINGE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON, S.A. BD DISCARDIT¿ II PISTON SYRINGE Back to Search Results
Catalog Number 300296
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2022
Event Type  malfunction  
Event Description
It was reported that the bd discardit¿ syringe experienced leakage. The following information was provided by the initial reporter: hospital pharmacists have had an leakage issue with 20 ml discardit syringes for a long time.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each additional lot number is as follows: medical device lot #: 2204187. Medical device expiration date: 31-mar-2022. Device manufacture date: 02-apr-2022. Medical device lot #: 2205129. Medical device expiration date: 30-apr-2027. Device manufacture date: 04-may-2022.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD DISCARDIT¿ II
Type of DevicePISTON 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 Key15317418
MDR Text Key300450311
Report Number3002682307-2022-00223
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFI
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 09/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number300296
Device Lot NumberSEE H10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-