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

Catalog Number	381911
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
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-n autoguard winged needle pierced the catheter.The following information was provided by the initial reporter, translated from french to english: the canula perforates the catheter on insertion.This time, 3 catheters have been kept, and i can make them available to you if necessary.I'm also enclosing a photo of the devices.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the photograph and sample submitted for evaluation.Bd received one photo and 3 24 g x 0.56 in insyte autoguard devices from lot number 3180656.Inspection of the photo showed that the devices have their needle protruding the catheter walls.A v-shape hole was identified in two of the three returned iv catheters.The shape and size of the hole was consistent with needle puncture damage.As the device has been opened, it could not be determined with certainty whether the damage originated during manufacturing or use of the device.Although your reported issue was confirmed, there were no distinguishing features which could aid in identification of a specific root cause.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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: 20427921
• Report Number: 1710034-2024-01133
• Device Sequence Number: 8735771
• Product Code: FOZ
• UDI-Device Identifier: 00382903819119
• UDI-Public: (01)00382903819119(11)230629(17)260531(10)3180656
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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: 05/31/2026
• Device Catalogue Number: 381911
• Device Lot Number: 3180656
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown