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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

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BD (SUZHOU) BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383715
Device Problem Leak/Splash (1354)
Patient Problem No Code Available (3191)
Event Date 10/05/2020
Event Type  Injury  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that the bd pegasus safety closed iv catheter system was used to infuse liquid into the patient, who left the hospital only to return "10 minutes" later. The end cap had fallen off as a result of q-syte damage, so the needle was removed and the patient was "disinfected and pressed". The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2020, the family members took the child away from the hospital after the completion of liquid injection and tube sealing. About 10 minutes later, the family members brought the child back to the infusion room. It was found that the heparin cap had fallen off, the child's indwelling needle was taken out, and the child was disinfected and pressed. ".
 
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Brand NameBD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
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 Key10920389
MDR Text Key218721027
Report Number3006948883-2020-00857
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
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 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383715
Device Lot Number0019695
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 Received01/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2020
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: 11/30/2020 Patient Sequence Number: 1
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