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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) PEGASUS GN 18GA X 1.16IN PRN-CAP Y CATHETER
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BD (SUZHOU) PEGASUS GN 18GA X 1.16IN PRN-CAP Y CATHETER Back to Search Results
Catalog Number 383952
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 11/16/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that pegasus gn 18ga x 1. 16in prn-cap y package was damaged. The following information was provided by the initial reporter: during daily routine inspection, the outer package of the closed needle puncture proof vein indwelling needle is found to be damaged, it was replaced immediately and reported to the equipment department.
 
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Brand NamePEGASUS GN 18GA X 1.16IN PRN-CAP Y
Type of DeviceCATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer (Section G)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11152511
MDR Text Key227110179
Report Number3006948883-2021-00052
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 02/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/12/2023
Device Catalogue Number383952
Device Lot Number0078906
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 Received02/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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