MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 BD Intraosseous Vascular Access System; Intraosseous Needle

Model Number	N/A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information received 30-jul-2026: patient did not have any other vascular access available during transport to the emergency department.Patient expired.Patient was in respiratory arrest when the first io needle was attempted.
Event or Problem Description
It was reported by customer that a provider attempted humeral access using one yellow needle.The attempt resulted in immediate mechanical failure, with the needle shaft bending and the tip rolling over.Due to the inability to secure io access, the decision was made to expedite transport to the emergency department without further invasive interventions (rsi).
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 customer reported the patient passed away but did not provide the patient's date of death.The date in this report is the date bd became aware of the patient's death.
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.

• Brand Name: BD Intraosseous Vascular Access System
• 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 84116
• Manufacturer Contact: chelsea raehl ; 605 north 5600 west; salt lake city 84116 ; +1(801)595-0700
• MDR Report Key: 50161528
• Report Number: 3006260740-2026-05544
• Device Sequence Number: 10572202
• Product Code: FMI
• UDI-Device Identifier: 00801741163609
• UDI-Public: (01)00801741163609
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K191976
• 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
• Report Date (Section B): 08/08/2026

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: Unknown
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Supplement Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2025
• 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: Death; Other
• Patient Sex: Unknown