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 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.
 
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
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 15-apr-2022.H6: investigation summary: a device history review was conducted for lot number 0357658.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally a sample was returned to aid in our investigation.During visual analysis our engineers noted that the extension tubing of the returned sample was not seated in the adapter body.This would have lead to the observed leakage experienced by the facility, the issue has been confirmed.Closer inspection of the metal tubing cuff identified a lack of swaging.In response to this non-conformance, our engineers have reviewed our manufacturing process, the swaging station used, and the manufacturing logs for this lot.They were unable to identify any evidence of complications or deviations from expected manufacturing line performance.Unfortunately the root cause for this event could not be determined at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM
Type of Device
INTERVASCULAR 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
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/20/2024
Device Catalogue Number383725
Device Lot Number0357658
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/01/2022
Initial Date FDA Received03/15/2022
Supplement Dates Manufacturer Received04/26/2022
Supplement Dates FDA Received05/05/2022
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
Patient Sequence Number1
-
-