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

Catalog Number	381911
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that bd insyte-n autoguard winged needle pierced through the catheter the following information was provided by the initial reporter translated from french to english: catheter intact when opened.When i wanted to infuse the baby, i pricked, blood returned but difficulty fitting the catheter.Withdrawal of the catheter, the needle had pierced the catheter.Description of consequences: infusion failure, hematoma.
Additional Manufacturer Narrative
The complaint that the needle pierced the catheter was confirmed from the photograph that was provided for investigation.The photo showed a 24g insyte autoguard with evidence of use.What appeared to be blood residue was observed within the catheter, catheter adapter, and needle hub.The safety mechanism had not been activated.The needle was protruding through the catheter and appeared to be bent near the puncture site in the catheter tubing.The catheter conformed to the bend in the needle.Due to the evidence of use, the catheter was likely withdrawn and subsequently reinserted into the catheter during the insertion procedure.The instructions for use (ifu) warn, "if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert the needle into the catheter tubing as damage may occur.".
Additional Manufacturer Narrative
Physical sample received: the physical unit received for investigation appears to be the unit shown on the photograph.The needle is protruding the catheter wall near the base of the adapter.This type of defect is known as spear through and although could be manufacturing related, the defect observed likely occurred in the user environment as the shown defect would have render the device unusable.It is likely that the defect occurred during use when performing venipuncture.The needle was inspected under the microscope and no other physical damages was observed investigation conclusion(s): the defect of ¿catheter defective/damaged/needle through catheter¿ was confirmed.Probable root cause conclusion(s): due to the evidence of use, the catheter was likely damaged during the insertion process.
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE-N 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) ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 18332404
• Report Number: 1710034-2023-01445
• Device Sequence Number: 8424943
• Product Code: FOZ
• UDI-Device Identifier: 30382903819110
• UDI-Public: (01)30382903819110
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2024

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: 03/31/2026
• Device Catalogue Number: 381911
• Device Lot Number: 3111935
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 01/23/2024; 02/23/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/30/2024; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown