• 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 (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

  • 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 (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM Back to Search Results
Catalog Number 383732
Device Problem Leak/Splash (1354)
Patient Problem No Code Available (3191)
Event Date 08/06/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that leakage occurred with a bd pegasus¿ safety closed iv catheter system. The following information was provided by the initial reporter ((b)(6) translation), "the patient is a pregnant woman with threatened abortion and abortion. It takes a long time to enter the atosiban solution to inhibit the contraction of the contraction. The indwelling needle is used for infusion. The infusion pump controls the amount and speed of the input fluid, and adjusts the infusion rate to 2 ml/h. At 12:00 a. M. On (b)(6) 2019, the patient has been given venous puncture. The bd-safe 22ga indwelling needle was selected, and the prn was checked before operation. At 03:00 a. M on the (b)(6) 2019, medical personnel replaced position of the tube clamp in the infusion pump according to the doctor's order. 5 minutes later, it's noticed that blood leakage at prn connection site. Such problems may cause blood loss anemia and even hemorrhagic shock in patients. In addition, in order to prevent infection issue, replaced new indwelling needle for patient and lead to patient's sensitivity and anxiety. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
Type of DeviceIV CATHETER SYSTEM
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8970739
MDR Text Key158145694
Report Number8041187-2019-00709
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
PENDING
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2021
Device Catalogue Number383732
Device Lot Number8235267
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/25/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/06/2019 Patient Sequence Number: 1
-
-