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

Catalog Number	381444
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
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 blood splatter.The following information was provided by the initial reporter: blood splattered on nurse when the needle was safteyed.Blood got on the nurses body and scrubs.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the sample submitted for evaluation.Bd received one needle with safety shield from an 18g x 1.16 in insyte autoguard device from lot number 3320957.The needle was received fully retracted within the safety shield.What appeared to be blood residue was visible within the flash chamber/needle hub, which indicates that the needle accessed the vessel during the insertion process.A microscopic examination revealed that no blood leaked from the flow control plug.The presence of gel was also observed to be smeared within the safety shield.The gel was used to dampen the retraction force.A drop of blood was noted within the grip near the spring and white button, which was considered circumstantial evidence that blood likely splattered during needle retraction.The 18g iv catheter was not provided for investigation.The returned sample was not a blood control device and it could not be determined how much blood had filled the catheter adapter before the safety mechanism had activated.Had the catheter adapter been full of blood, the activation of the safety mechanism may have caused some blood to escape when the needle retracted.No defects associated with the manufacturing process were noted on the returned sample.Although your reported issue was confirmed, a root cause could not be determined due to the condition of the returned sample.The instructions for use (ifu) provide guidance to reduce the amount of blood flow into the catheter, such as the use of a tourniquet and applying venous compression before activating the safety mechanism.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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: 19498442
• Report Number: 1710034-2024-00539
• Device Sequence Number: 20498375
• Product Code: FOZ
• UDI-Device Identifier: 00382903814442
• UDI-Public: (01)00382903814442
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: Health Professional
• Device Catalogue Number: 381444
• Device Lot Number: 3320957
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown