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

Catalog Number 381034

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Foreign Body Embolism (4439)

Event Date 03/05/2024

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 autog bc global catheter separated.The following information was provided by the initial reporter, translated from spanish to english: hospitalized patient with peripheral venous line of bd (20g) is removed his short peripheral catheter 20g of bd, this access is used for 3 days to administer bolus infusion therapies, on the third day the nurse on duty removes the venous line and the catheter is cut almost from the base leaving a large portion of the input inside the patient.During the use of the catheter in the patient, adequate maintenance is performed according to the institution's guidelines (turbulent washing before and after medication).

Event Description

Additional information: has there been any harm to patients/healthcare professionals? a: yes - temporary harm to the patient.When did this event occur, before, after or during the procedure? a: during use.Was there a need for medical and/or surgical intervention due to what happened (imaging exams, surgery, medication administration, etc.)? (detail) a: degree of damage caused temporary damage and required intervention (e.G., further surgery, supplemental treatment).Surgical intervention, supplementary treatment.

Manufacturer Narrative

Investigation results: the complaint of a broken catheter was confirmed from the photograph that was provided for investigation.The photo showed a 20g insyte autoguard iv catheter with evidence of use.The catheter tubing was broken near the catheter adapter.A short segment of tubing remained attached to the catheter adapter.Without the physical sample or better images of the adjoining ends of the catheter, the root cause could not be determined.Potential contributing factors include material fatigue or sharp instrument damage.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.

• Brand Name: BD INSYTE AUTOG BC GLOBAL
• 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: 18999674
• MDR Text Key: 339242156
• Report Number: 1710034-2024-00255
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903810345
• UDI-Public: (01)00382903810345
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 381034
• Device Lot Number: 3228139
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention