MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 Intraosseous Needle Kits

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported by the customer that they had a failed io attempt with a defective needle over the weekend.Emts arrived on the scene of a 47 year old male in cardiac arrest.They started high-performance cpr, providing compressions, securing the airway, and attaching the patient to the aed.E207 emts arrived a few minutes later.This crew was tasked with obtaining io access in the right humeral head.The lieutenant removed the io case from their red ems bag and pulled out the drill and yellow needle.He then put the needle onto the drill and located the access point for the patient's right humeral head.He inserted the needle into the arm until he felt it touch the bone and then activated the drill, stopping once the io had been set into place.He pulled the drill straight back and set it next to the patient and then attempted to attach the included tubing only to identify that the internal needle had not been removed from the drill site.He made several attempts to twist the needle to remove it and was unable to get the inner portion free.Three other medics also attempted to remedy the situation with no success.A second io was placed in the tibia and they were able to use this site for the duration of the call.Later, as a paramedic from the original emt crew was working the airway, he reached own, twisted the top of the io to the left, and the io needle pulled right out.Ultimately the patient was pronounced dead at the scene.
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.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.The device has not been returned to the manufacturer for evaluation.

• Brand Name: Intraosseous Needle Kits
• Common Device Name: Intraosseous Needle
• 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: chelsea raehl ; 605 north 5600 west; salt lake city 84116 ; +1(801)595-0700
• MDR Report Key: 50775085
• Report Number: 3006260740-2026-06713
• Device Sequence Number: 21444024
• Product Code: FMI
• UDI-Device Identifier: 00801741163609
• UDI-Public: (01)00801741163609(11)260520(17)290413(10)BSLC13956
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 08/28/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: D015451NK
• Device Lot Number: BSLC13956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2026
• 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: Death; Required Intervention; Life Threatening
• Patient Age: 47 YR
• Patient Sex: Male