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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS RADSTIC RADIOLOGY MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 1 INTRODUCER, CATHETER

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BARD ACCESS SYSTEMS RADSTIC RADIOLOGY MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 1 INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); Tachycardia (2095)
Event Date 03/17/2020
Event Type  Death  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of redw0118 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that for an infant (b)(6), with a history of bronchiolitis hospitalized in a sheave with non-invasive ventilation support and then discharged to general pediatrics for further treatment. Readmitted for endocarditis with antibiotic treatment required for 6 weeks. Catheter installation on (b)(6) at 5 p. M. To be able to carry out the treatment. Transfusion necessary for the end of a bradycardia then abrupt stop at 10. 00 pm (5h after installation), immediately taken care of on compression hemopericardium, tamponade and transfer to intensive care unit, unfavorable development and death the next day at 5 p. M.
 
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Brand NameRADSTIC RADIOLOGY MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 1
Type of DeviceINTRODUCER, 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
kayla olsen
605 n. 5600 w.
salt lake city, UT 84116
8015225010
MDR Report Key9984253
MDR Text Key188438837
Report Number3006260740-2020-01471
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00801741074578
UDI-Public(01)00801741074578
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K915167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 05/08/2020
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? No
Device Operator
Device Expiration Date11/30/2021
Device Model NumberN/A
Device Catalogue Number0669045
Device Lot NumberREDW0118
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2019
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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