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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PEGASUS YEL 24GA X 0.75IN PRN-CAP Y; INTRAVASCULAR CATHETER
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BD SUZHOU (MDS) BD PEGASUS YEL 24GA X 0.75IN PRN-CAP Y; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383712
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2024
Event Type  malfunction  
Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
 
Event Description
It was reported that bd pegasus yel 24ga x 0.75in prn-cap leaked the following information was provided by the initial reporter: during the patient's infusion process, it was discovered that the indwelling needle was leaking.Leakage.
 
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Brand Name
BD PEGASUS YEL 24GA X 0.75IN PRN-CAP Y
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BD SUZHOU (MDS)
#5 baiyu road
suzhou industrial park
jiangsu 21502 1
CH  215021
Manufacturer (Section G)
BD SUZHOU (MDS)
#5 baiyu road
suzhou industrial park
jiangsu 21502 1
CH   215021
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key19003574
MDR Text Key339057806
Report Number3002601200-2024-00110
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number383712
Device Lot Number2196016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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