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

Model Number	N/A
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.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 by customer that difficulty separating needle and obturator.No further details provided.It was reported this occurred with 3 devices.This report addresses all 3 devices.
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 product returned for evaluation was three 15mm intraosseous (io) needles.All three samples were received in their original sealed packaging.Visual inspection of the needle/obturator assemblies was unremarkable.During manipulation, the needle luers felt loose within the obturator hubs.Removal of the obturators was successful and unremarkable.No resistance was encountered.Needle and obturator hub features were measured using a digital microscope and a top-down viewing angle.Those measurements were compared against the specifications.Several dimensions were found to be outside of manufacturing specifications.Those measurements are demonstrated in the attached photographs.Reference the attached photos field in the investigation overview tab.The obturators were successfully removed from the needle shafts; however, the loose fit between the obturator and needle hubs may contribute to difficult separation following drilling procedures.The loose fit was caused by the two components being manufactured outside of specifications.This appeared to have occurred during the molding process.The affected products were manufactured prior to molding equipment updates.The returned samples were sealed, indicating they were not the products used in the field.While components were found to be outside of manufacturing specifications, it is unknown if these features contributed to reported difficulty separating the obturator from the needle.

• Brand Name: 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 UT 84116
• Manufacturer Contact: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24903677
• Report Number: 3006260740-2026-02583
• Device Sequence Number: 9928232
• Product Code: FMI
• UDI-Device Identifier: 00801741163586
• UDI-Public: (01)00801741163586(11)250614(17)261116(10)BSLC10526
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K191976
• 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): 04/27/2026

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: D015151NK
• Device Lot Number: BSLC10526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2025
• 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