MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD; PERIPHERAL IV CATHETERS

Catalog Number 381812

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 01/23/2024

Event Type  Injury  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd insyte autoguard used in patients that have acquired superficial vein thrombosis (venous cord).The following information was provided by the initial reporter, translated from spanish to english: we have noticed in the newborn unit a significant increase in phlebitic reactions such as: redness in the area of the catheter, redness in the area of the vein, sometimes superficial venous thrombosis (venous cord), so we kindly ask you to review the brand and batches of peripheral catheters that you are sending to the peripheral catheters that are being sent to the service, in order to guarantee the safety of the care provided to our patients.I request to review batch we have two reports from the newborn unit.

Manufacturer Narrative

The customer response confirms that no serious injury occurred and that there was no device malfunction evident.Cancel mdr.

Event Description

Was there a need for medical and/or surgical intervention due to what happened (imaging tests, surgery, administration of drugs, etc.)? (detail) answer: catheter removal and exchange is performed.Was there exposure of blood/chemotherapy to mucous membranes (eyes, nose and mouth) or skin? if yes, indicate whether the exposure was from the patient or the practitioner and what measures were taken.(detail).Answers: no.What medication was being administered? answer: ampicillin and dextrose were being administered.What was the additional medical treatment needed for each defined patient? answer: the patient listed in the safety event required a catheter change.Could you please conform the number of events that occurred? answer: to date two related incidents are found.To help identify the problem with the device: did you identify any specific device deformities of the probe or catheter? any visible problems with the physical construction of the catheter? response: according to the in-service review, no physically visible problems were evident with the catheter.It is stated that the catheters were removed.Answer: the catheters were removed.What treatment did the patients require due to the reported events? answer: catheter change and insertion limb to provide continuity of drug therapy.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: PERIPHERAL IV CATHETERS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18707478
• MDR Text Key: 335406434
• Report Number: 1710034-2024-00103
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: (01)00382903818129
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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: Health Professional
• Device Catalogue Number: 381812
• Device Lot Number: 3192261
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other