MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD WINGED PNK 20GA X 1.16I; INTRAVASCULAR CATHETER

Catalog Number	381534
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autoguard winged pnk 20ga x 1.16i leaked.The following information was provided by the initial reporter: "continuous leak from angiocath once iv inserted.".
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 added to b5 investigation results: our quality engineer inspected the sample submitted for evaluation.Bd received one unsealed and retracted 20ga x 1.16in.Insyte autoguard winged unit from lot number 3342338.A leak test was performed where no leaks were discovered.Visual inspection discovered there was media present indicating usage.No damage to the vent plug was discovered that may have indicated leaks in the barrel.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failure stated in your report.A device history record review showed no non-conformances associated with this issue during the production of these batches.
Event or Problem Description
Additional infromation: 1) what injury occurred because of this event? no injury occurred, just required multiple iv sticks despite initial good iv.2) were surgical or medical interventions needed to resolve this issue? if so, what? only intervention was holding pressure for iv site to stop bleeding.4) was there report of exposure of blood/body fluids to another person's wounds or mucosal surfaces? no appropriate precautions were taken with known possible exposure to blood.Room required floor cleaning due to blood which was handled appropriately.5) was there any delay in treatment due to this? not sure if the or/ pre-op experienced any delays as a result.6) was there any change in treatment due to the leakage? no change in treatment, except requiring additional sticks for iv, by additional staff.

• Brand Name: BD INSYTE AUTOGUARD WINGED PNK 20GA X 1.16I
• 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: 18821914
• Report Number: 1710034-2024-00147
• Device Sequence Number: 19978287
• Product Code: FOZ
• UDI-Device Identifier: 00382903815340
• UDI-Public: (01)00382903815340
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/15/2024

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 Catalogue Number: 381534
• Device Lot Number: 3342338
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown