MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BD INTRAOSSEOUS VASCULAR ACCESS SYSTEM; INTRAOSSEOUS NEEDLE KIT

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	01/27/2026
Type of Reportable Event	Malfunction
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 an io needle bent during a recent training event in a cadaver lab.
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 35 mm intraosseous (io) needle.The sample was received with its opened packaging.The sample was received assembled, with the obturator inlaid through the needle shaft.Usage residues were observed at the needle tip.The needle shaft was bent at the base, just distal of the luer adapter.The tip of the needle appeared deformed.Microscopic inspection of the needle confirmed tip deformation.The needle tip was curled and exhibited material flow throughout the deformed region.The bend in the needle shaft appeared consistent with excessive pressure applied during attempted device placement.The tip deformation and material flow suggested that resistance was encountered during the drilling process, potentially due to contact with a hard surface, such as a metal implant.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: BD INTRAOSSEOUS VASCULAR ACCESS SYSTEM
• 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: becky sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24423211
• Report Number: 3006260740-2026-01081
• Device Sequence Number: 5917172
• Product Code: FMI
• UDI-Device Identifier: 00801741163593
• UDI-Public: (01)00801741163593(11)250716(17)280612(10)BSLC10874
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K203193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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 Model Number: N/A
• Device Catalogue Number: D015351NK
• Device Lot Number: BSLC10874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• 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: Other
• Patient Sex: Unknown