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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER
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BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383851
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2021
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 the bd pegasus¿ safety closed iv catheter system experienced leakage.The following information was provided by the initial reporter: when the patient was given fluid rehydration, it was found that the connection of the closed indwelling needle was leaking and could not be used.The indwelling needle was replaced and re-punctured for fluid rehydration.Position of leakage: the position of the connection between the extension pipe and the extension pipe seat is leakage.Disposal: pull out the indwelling needle and re-puncture.
 
Manufacturer Narrative
H6: investigation: a device history review was conducted for lot number 9078572.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
 
Event Description
It was reported that the bd pegasus¿ safety closed iv catheter system experienced leakage.The following information was provided by the initial reporter: when the patient was given fluid rehydration, it was found that the connection of the closed indwelling needle was leaking and could not be used.The indwelling needle was replaced and re-punctured for fluid rehydration.Position of leakage: the position of the connection between the extension pipe and the extension pipe seat is leakage.Disposal: pull out the indwelling needle and re-puncture.
 
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Brand Name
BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
Type of Device
INTRAVASCULAR CATHETER
MDR Report Key12356807
MDR Text Key267835565
Report Number3014704491-2021-00094
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
PENDING
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 08/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/28/2022
Device Catalogue Number383851
Device Lot Number9078572
Was Device Available for Evaluation? No
Date Manufacturer Received08/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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