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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Tachycardia (2095)
Date of Event	03/17/2020
Type of Reportable Event	Death
Additional 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 or Problem 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.
Event or Problem Description
It was reported that a 5 week old patient was admitted to the hospital in the intensive care unit for bronchiolitis, respiratory syncytial virus, endocarditis with staphylococcus aureus methicilline-sensible.At the time of admission the patient was anemic but otherwise not in any respiratory distress.The cvc was place for antibiotic treatment on (b)(6) 2020.The cvc was placed with some bleeding at the insertion site and the patient was reportedly tachycardic (attributed by the physician to the anemia).Placement was confirmed with x-ray and the tip of the catheter was reportedly in the upper 1/3 of the right atrium.The next day, the patient remained tachycardic related to the anemia.The patient went into cardiac arrest.During resuscitation, a cardiac ultrasound showed circumferential pericardial effusion.Resuscitation efforts, which included pericardial drainage and external cardiac massage were unsuccessful and the patient died.The reported documented cause of death was cardiac arrest due to pericardial tamponade.An autopsy was not performed and the death certificated is reportedly not available.
Additional 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 returned to the manufacturer for evaluation.A lot history review (lhr) of redw0118 showed no other similar product complaint(s) from this lot number.

• Brand Name: RADSTIC RADIOLOGY MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 1
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9984253
• Report Number: 3006260740-2020-01471
• Device Sequence Number: 19603560
• Product Code: DYB
• UDI-Device Identifier: 00801741074578
• UDI-Public: (01)00801741074578
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K915167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 0669045
• Device Lot Number: REDW0118
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Weight: 3