• 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 MEDICAL DEVICES CO., LTD. SUZHOU BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER

  • 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 MEDICAL DEVICES CO., LTD. SUZHOU BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383725
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2022
Event Type  malfunction  
Event Description
It was reported that the bd pegasus safety closed iv catheter system became loose and leaked blood during use. The following information was provided by the client: "during puncture in ct room, the joint between the indwelling needle and the prn became loose and leaked blood".
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH 215126
Manufacturer (Section G)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH 215126
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13773348
MDR Text Key287680707
Report Number3014704491-2022-00102
Device Sequence Number1
Product Code FOZ
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,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383725
Device Lot Number0357658
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-