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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) PEGASUS BL 22GAX1.00IN PRN-CAP Y NON-PVC N/A

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BD (SUZHOU) PEGASUS BL 22GAX1.00IN PRN-CAP Y NON-PVC N/A Back to Search Results
Catalog Number 383736
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Code Available (3191)
Event Date 03/31/2020
Event Type  Injury  
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 bl 22gax1. 00in prn-cap y non-pvc catheter separated during use. The following information was provided by the initial reporter: the cardiovascular and neurosurgery nurse found that the patient's indwelling needle was detached from the body at 3:30 on (b)(6) 2020. The indwelling needle catheter was lost. The patient had no self-consciousness and only his left arm could move. X-ray imaging of the upper body revealed no catheter in the body. No catheter was found outside the body.
 
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Brand NamePEGASUS BL 22GAX1.00IN PRN-CAP Y NON-PVC
Type of DeviceN/A
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
8015652341
MDR Report Key9981006
MDR Text Key188672030
Report Number3006948883-2020-00140
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 04/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2022
Device Catalogue Number383736
Device Lot Number9168730
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 Received03/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2019
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: 04/21/2020 Patient Sequence Number: 1
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