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

Catalog Number	381844
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that bd insyte autoguard catheter is defective.The following information was provided by the initial reporter, translated from spanish to english: on (b)(6)2024 a broken catheter is evidenced and the patient is punctured twice.This event implies an increase of supplies in the services, and multifunction to the patient.Additional information received on 11/18/2024.Has there been any harm to patients/healthcare professionals? a: no there was no damage to the patient, the catheter broke, so it was necessary to change it and perform a double procedure on the patient.Could you share the photo samples of the incident? photographic evidence is added was there a need for medical and/or surgical intervention due to the incidence (imaging tests, surgery, drug administration, etc.)? (detail) a: not necessary.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).A: no exposure occurred.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: the complaint of a damaged catheter was confirmed; however, the root cause could not be determined from the photographs that were provided for investigation.The photos showed an 18g insyte autoguard iv catheter, which had been separated from the needle.Something was protruding from the external surface of the catheter tubing; however, the source and composition of the matter could not be determined from the photograph.As the photo supports the complainant¿s description of the reported event, the complaint was confirmed; however, without the physical sample, the root cause of the reported issue could not be determined.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.A trend was identified for the reported failure and corrective actions have been implemented to investigate this type of incident and identity the root cause.Review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• Brand Name: BD INSYTE AUTOGUARD
• Common Device Name: 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: 20859386
• Report Number: 1710034-2024-01438
• Device Sequence Number: 11779637
• Product Code: FOZ
• UDI-Device Identifier: 00382903818440
• UDI-Public: (01)00382903818440(11)240620(17)270531(10)4170687
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 381844
• Device Lot Number: 4170687
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Male