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

Catalog Number	381444
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autoguard safety barrel filled with blood/blood spatter.The following information was provided by the initial reporter: mechanism looks to have failed causing excessive blood spatter a unit supervisor is asking if this is a defect, angiocath chamber doesn¿t usually fill like this, the blood splattered when she hit the safety button.
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.E1.Street address information was not provided, therefore, xx was used as a place holder.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the photographs submitted for evaluation.Bd received three photographs which displayed the safety shield from the implicated autoguard iv catheter.The needle had ben retracted and the catheter had been fully deployed off of the finger grip.The catheter was not within the frame of the photograph.In one of the photographs, the safety shield was laid out on a green sheet or drape while in the other photograph the device was held in a gloved hand.Multiple splatters of red fluid, consistent with blood, were seen on the green sheet or drape.The splatters varied in size and location.The barrel of the safety shield was completely full of the red fluid.There appeared to be a lighter section in the end of the barrel which appeared consistent with the flow control plug.Your reported issue was confirmed.Without examination of the physical sample, the exact cause of the excessive blood filling the barrel and blood splattering from the device could not be determined.It is possible for fluid exposure to occur if there is a manufacturing issue where the flow control plug becomes damaged or the flow control plug is set to an improper depth.Manufacturing controls are in place to minimize the occurrence of this type of damage including machine set-up per the controlled procedure, vision system inspections, in-process sampling tests for leaks past the plug and plug depth inspections.Clinical causes for the barrel filling with blood could include pausing with the needle tip within the vein for an excessive amount of time.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: 19731494
• Report Number: 1710034-2024-00707
• Device Sequence Number: 18179606
• Product Code: FOZ
• UDI-Device Identifier: 00382903814442
• UDI-Public: (01)00382903814442
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 381444
• Device Lot Number: 3181569
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown