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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 18 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS 18 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT INTRAVASCULAR CATHETER Back to Search Results
Model Number N/A
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Inflammation (1932); Pain (1994); Thrombosis (2100)
Event Type  Injury  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that the powerglide was inserted via ultrasound (sonosite as siterite8 used for picc insertions) in the upper arm right brachial vein for iv antibiotic infusions. The dvt was diagnosed via doppler ultrasound and symptoms of swollen arm and pain less than two weeks after placement. Dvt was treated with low molecular weight heparin. The line was removed. It was stated after removal one of the brachial veins was thrombosed and incompressible from ~1. 0cm from the level of the arm pit to mid upper arm and measures ~14cm in length.
 
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Brand Name18 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key6966727
MDR Text Key89918565
Report Number3006260740-2017-01876
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741138607
UDI-Public(01)00801741138607
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Radiologic Technologist
Type of Report Initial
Report Date 10/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number6F118100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/20/2017 Patient Sequence Number: 1
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