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

Catalog Number	382612
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autog bc wing catheter with a hole in the side.The following information was provided by the initial reporter: when inserting an iv catheter on a patient.I started advancing the catheter and had no resistance.I then retracted the needle.I then attached a j-loop to the patient iv.I attempted to draw back blood but only got air in the tube and a small amount of blood.I then tried to pull the catheter back to see if i was on a valve, however, i then noticed a small hole in the side of the catheter that was leaking blood.
Additional Manufacturer Narrative
A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the sample submitted for evaluation.Bd received one catheter assembly of a 24gx0.75in insyte autoguard device from lot number 3340237.The sample exhibited evidence of use.A hole was observed in the tubing, which may have been caused by the needle; however, it could not be determined how or when the catheter was damaged.Although your reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.During manufacturing, this may occur due to alignment of the set together station, bent tubing, or air blow inconsistency.There is a 100 percent automated vision system inspection and a sampling plan implemented for tip spear which mitigates the occurrence of this defect.However, as the returned has been removed from the package and handled it is possible that the defects originated due to improper use either during tip adhesion break or during the venipuncture attempt in the clinician environment.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD INSYTE AUTOG BC WING
• 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: 19358549
• Report Number: 1710034-2024-00461
• Device Sequence Number: 3770192
• Product Code: FOZ
• UDI-Device Identifier: 00382903826124
• UDI-Public: (01)00382903826124
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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: 382612
• Device Lot Number: 3340237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown