MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC WING YEL 24GA X .75IN; INTRAVASCULAR CATHETER

Catalog Number	382612
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blood control value malfunctioned with bd insyte autog bc wing yel 24ga x.75in.The following information was provided by the initial reporter: it was reported by customer that blood control value of the iv didn't work upon insertion.Blood control value of the iv didn't work upon insertion.Customer response received 02/20/2024 " iv stick (primary) was a ¿miss.¿ second iv was placed without incident.".
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Additional information: details on event added to b5 from customer.Investigation results: the complaint that the blood control value didn't work was confirmed from the circumstantial evidence of a damaged septum; however, the root cause could not be determined.One 24g insyte autoguard unit from lot #3153587 was provided for investigation.The sample exhibited evidence of use and the actuator had been advanced through the blood control valve.The actuator was removed and a microscopic examination of the septum revealed a tear in the septum at the terminus of one slit.As the device has been opened, it could not be determined with certainty whether the damage originated during manufacturing or use of the device.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.No other similar complaints were reported from this lot.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.
Event or Problem Description
Additional information from the customer: no mucosal exposure to hcp.Ppe was worn by hcp.No additional interventions necessary for hcp.It is unknown if the patient had a history of bloodborne disease.

• Brand Name: BD INSYTE AUTOG BC WING YEL 24GA X .75IN
• Common Device Name: INTRAVASCULAR 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18906584
• Report Number: 1710034-2024-00187
• Device Sequence Number: 7876534
• Product Code: FOZ
• UDI-Device Identifier: 00382903826124
• UDI-Public: (01)00382903826124
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2024

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: Other
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 382612
• Device Lot Number: 3153587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown