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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SITE~RITE 8 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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SITE~RITE 8 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Catalog Number 9770550
Device Problem Device Sensing Problem (2917)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/20/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not been received by the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
 
Event Description
During x-ray review that showed the picc tip curled back on itself in the basilic vein.The sherlock 3cg demonstrated an elevated p wave with the tip followed to a green diamond ¿lollipop¿.The inserter reported no issues with insertion and flash back and flushed with ease.The cxr was taken directly post insertion this report is for the second of three events reported.
 
Manufacturer Narrative
H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been received by the manufacturer for evaluation.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.
 
Event Description
During x-ray review that showed the picc tip curled back on itself in the basilic vein.The sherlock 3cg demonstrated an elevated p wave with the tip followed to a green diamond ¿lollipop¿.The inserter reported no issues with insertion and flash back and flushed with ease.The cxr was taken directly post insertion this report is for the second of three events reported.Additional details: (b)(6) 2019: picc placed with nil issues.Elevated p wave on 3cg.Attended cxr on completion of insertion.Reported to be in ijv by radiologist.Trouble shooting applied in this case and successfully migrated to mid svc.
 
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Brand Name
SITE~RITE 8 ULTRASOUND SYSTEM
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
MDR Report Key9685044
MDR Text Key193649393
Report Number3006260740-2020-00463
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741098208
UDI-Public(01)00801741098208
Combination Product (y/n)N
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9770550
Device Lot NumberN/A
Was Device Available for Evaluation? No
Event Location Hospital
Date Manufacturer Received02/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age49 YR
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