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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD SUZHOU (MDS) BD PEGASUS Y 24GA X 0.75IN SS PRN NPVC; INTRAVASCULAR CATHETER
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BD SUZHOU (MDS) BD PEGASUS Y 24GA X 0.75IN SS PRN NPVC; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383904
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2024
Event Type  malfunction  
Event Description
It was reported that bd pegasus y 24ga x 0.75in ss prn npvc had foreign matter the following information was provided by the initial reporter: the indwelling needle is inoperable with a foreign body at the tip.
 
Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
 
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Brand Name
BD PEGASUS Y 24GA X 0.75IN SS PRN NPVC
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 Key19197412
MDR Text Key341851128
Report Number3002601200-2024-00153
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 Other,Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383904
Device Lot Number3289309
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/03/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/16/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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