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

Catalog Number	381523
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
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 winged needle pierced the catheter resulting in an inability to retract the needle.The following information was provided by the initial reporter: i was starting an iv.Then observed kinking under the skin while advancing the catheter.Tried to retract needle, but it would not.Iv carefully removed and it was noted that needle had gone through catheter.The needle had remained in the catheter the whole time.Rn did not manipulate the needle in and out of the catheter.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.None.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed the implicated 22g winged insyte autoguard with the needle protruding through the catheter.The sample exhibited evidence of use.Due to the presence of what appeared to be blood residue between the catheter tip and the needle puncture site, it appeared that the catheter was able to access the vessel.The needle likely punctured the tubing after insertion.The instructions for use (ifu) state, "if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert the needle into the catheter tubing as damage may occur." furthermore, the device likely did not retract due to the damage observed of the needle piercing the catheter wall.No defects associated with the manufacturing process could be identified from the photograph.Manufacturing controls are in place to mitigate the occurrence of this type of failure.A device history record review could not be performed as the lot number is unknown.
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE AUTOGUARD WINGED
• 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: 20330184
• Report Number: 1710034-2024-01053
• Device Sequence Number: 9728199
• Product Code: FOZ
• UDI-Device Identifier: 00382903815234
• UDI-Public: (01)00382903815234
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 381523
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 09/29/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown