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

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Unintended Loss of Vascular Access (4867)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stylet separation failure involving the bd intraosseous (bd io) system used by our fire rescue members.During a recent patient encounter, our crew experienced a situation in which multiple stylets would not disengage from the needle hub after successful insertion, rendering the io nonfunctional and requiring immediate abandonment of the site.Stylet remained firmly fixed in the hub despite proper technique, stabilization, and controlled traction.The needle assembly appeared fully seated on the driver, but the stylet could not be removed (other attempts were made to remove the needle from the hub).A specific number of affected devices or patients was not provided by the complainant.
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.
Additional Manufacturer Narrative
Initial medwatch report was submitted, upon further review it was found that this medwatch report 3006260740-2026-00298 is a duplicate file and has been voided.The original event was submitted on medwatch report 3006260740-2026-00093.

• Brand Name: INTRAOSSEOUS NEEDLE KIT
• 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 84116
• Manufacturer Contact: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24211882
• Report Number: 3006260740-2026-00298
• Device Sequence Number: 18547846
• Product Code: FMI
• UDI-Device Identifier: 00801741163678
• UDI-Public: (01)00801741163678(11)250901(17)280807(10)BSLC11463
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 02/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: D015251NK
• Device Lot Number: BSLC11463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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