MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVENOUS CATHETER

Model Number 382533

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 08/10/2022

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter was involved with a patient experiencing muscle pains, paresthesia sensation, and hot flashes that persisted following device use.It has not been specified whether medical intervention was administered as a result.The following information was provided by the initial reporter, translated from french to english: following my radiology examination for a thorough medical diagnosis.This was a ct scan (thoracic ct) with intravenous injection of an iodinated radiological contrast agent.The overall course of the examination in question went well apart from a moderate pain experienced just when the injection device was introduced by placing a peripheral venous catheter in the vein of the elbow of the right arm.Having then scrupulously respected the instructions given at the end of the examination, i noticed the following day the presence of a diffuse redness (erythema) and a small ecchymosis located at the injection point of the contrast product associated with persistent muscular pains in the right deltoid and biceps brachii with a sensation of paresthesia in the right forearm up to the palm of the right hand (numbness, tingling, heaviness) and without any dissipation of the hot flashes.This unpleasant and anxiety-provoking symptomatology and clinical signs are still present to this day.

Manufacturer Narrative

H6: investigation summary since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter was involved with a patient experiencing muscle pains, paresthesia sensation, and hot flashes that persisted following device use.It has not been specified whether medical intervention was administered as a result.The following information was provided by the initial reporter, translated from french to english: following my radiology examination for a thorough medical diagnosis this was a ct scan (thoracic ct) with intravenous injection of an iodinated radiological contrast agent.The overall course of the examination in question went well apart from a moderate pain experienced just when the injection device was introduced by placing a peripheral venous catheter in the vein of the elbow of the right arm.Having then scrupulously respected the instructions given at the end of the examination, i noticed the following day the presence of a diffuse redness (erythema) and a small ecchymosis located at the injection point of the contrast product associated with persistent muscular pains in the right deltoid and biceps brachii with a sensation of paresthesia in the right forearm up to the palm of the right hand (numbness, tingling, heaviness) and without any dissipation of the hot flashes.This unpleasant and anxiety-provoking symptomatology and clinical signs are still present to this day.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15491518
• MDR Text Key: 300641393
• Report Number: 1710034-2022-00550
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825332
• UDI-Public: (01)00382903825332
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

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
• Device Operator: Other
• Device Model Number: 382533
• Device Catalogue Number: 382533
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 10/29/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Other