Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 POSIFLUSH SYRINGE; SALINE, VASCULAR ACCESS FLUSH
  • 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 POSIFLUSH SYRINGE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306573
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/28/2021
Event Type  malfunction  
Event Description
It was reported bd posiflush syringe was damaged.The following information was provided by the initial reporter: "syringe broken".
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary: a device history record review was completed for provided lot number 1005958.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.To aid in the investigation of this issue, one sample was returned for evaluation by our quality engineer team.The sample had no saline solution and the barrel component was cracked near the luer lock area.Based on the production history records, an exact circumstance could not be identified during the manufacturing process.
 
Event Description
It was reported bd posiflush syringe was damaged.The following information was provided by the initial reporter: "syringe broken".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD POSIFLUSH SYRINGE
Type of Device
SALINE, VASCULAR ACCESS FLUSH
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 Key13065058
MDR Text Key284810250
Report Number3002682307-2021-00668
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeTW
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 01/11/2022
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 Expiration Date12/31/2023
Device Catalogue Number306573
Device Lot Number1005958
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/29/2021
Initial Date FDA Received12/22/2021
Supplement Dates Manufacturer Received01/11/2022
Supplement Dates FDA Received01/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/05/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-