MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 INTRAOSSEOUS, INTRAOSSEOUS NEEDLE KITS

Model Number	N/A
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported during an attempted insertion, the 45mm bdio needle bent before it penetrated the patient's bone.No patient harm reported.No other information was provided.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The complaint of a bent needle was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 45mm intraosseous (io) needle.Usage residues were observed on the sample.The obturator was inlaid through the needle shaft.A bend was observed in the needle shaft near the luer adapter.The needle tip exhibited deformation.Microscopic inspection of the needle tip confirmed deformation.The needle tip was twisted and peeled away from the obturator tip.The obturator tip was folded toward the needle bevel.The bend in the needle shaft was consistent with sheer, or lateral stress placed on the needle shaft.The tip deformation was consistent with excessive force placed on the needle tip while the needle was rotating.The needle bend further suggested that force was applied while the needle was not placed at a 90 degree angle to the patient¿s skin.The product instructions for use (ifu) inform users to use moderate steady pressure when inserting the needle into the bone at a 90 degree angle to the skin.Positioning the needle in this fashion minimizes the amount of lateral pressure, reducing the risk of needle deformation/damage.Bd has prepared supplemental educational material pertaining to io products.An e-learning course, entitled fundamentals of intraosseous (io) device is currently available at academy.Bd.Com.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: INTRAOSSEOUS, INTRAOSSEOUS NEEDLE KITS
• Common Device Name: INTRAOSSEOUS NEEDLE KIT
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city UT 84116
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21941402
• Report Number: 3006260740-2025-02741
• Device Sequence Number: 9056399
• Product Code: FMI
• UDI-Device Identifier: 00801741163609
• UDI-Public: (01)00801741163609(11)241202(17)260309(10)BSLC7796
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2026
• Device Model Number: N/A
• Device Catalogue Number: D015451NK
• Device Lot Number: BSLC7796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown