MAUDE Adverse Event Report: TELEFLEX MEDICAL VASCULAR UNKNOWN DUMMY MATERIAL

Catalog Number VASCULAR UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Tissue Damage (2104); No Consequences Or Impact To Patient (2199)

Event Date 08/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Sampson cs.Extravasation from a misplaced intraosseous catheter.Clin pract cases emerg med.2019;3(3):303-304.A (b)(6) female presented by ems to the emergency department (ed) after she suffered a ventricular fibrillation cardiac arrest while out of hospital.She had return of spontaneous circulation prior to ed arrival after multiple defibrillations and treatment by ems including a right proximal tibial ezio intraosseous (io) catheter in place in which multiple medications had been administered including epinephrine, magnesium, amiodarone, and calcium chloride.The io catheter did not flush upon arrival in the ed and was removed; peripheral intravenous access was obtained.There was ecchymosis at the io insertion site on day 3 and the patient was discharged on day four.Three weeks post discharge the patient presented with tissue necrosis in an area surrounding the initial proximal tibial io insertion site.The patient's leg was debrided and grafting was performed; the author reported "good healing" three months post-event.

• Brand Name: VASCULAR UNKNOWN DUMMY MATERIAL
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 8977072
• MDR Text Key: 161338532
• Report Number: 3011137372-2019-00297
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VASCULAR UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention