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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. PEGASUS BL 22GAX1.00IN QSYTE-CAPY NONPVC INTRAVASCULAR CATHETER

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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. PEGASUS BL 22GAX1.00IN QSYTE-CAPY NONPVC INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383738
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 09/02/2019
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 has been reported that one pegasus bl 22gax1. 00in qsyte-capy nonpvc has been found experiencing leakage during use. The following has been provided by the initial reporter: it's noticed that leakage at q-syte (not the diaphragm on the q-syte,not the screw, leakage at conjunction site) and then the infusion set is closed. At this time, the blood is returned to the joint. The patient's blood leaked from the leak. Leaked blood confirmed to be a little. No adverse reaction on patient.
 
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Brand NamePEGASUS BL 22GAX1.00IN QSYTE-CAPY NONPVC
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
Manufacturer (Section G)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9082937
MDR Text Key178791559
Report Number3006948883-2019-00776
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 10/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/02/2022
Device Catalogue Number383738
Device Lot Number9023769
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 Received09/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/18/2019 Patient Sequence Number: 1
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