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	Product Quality Problem (1506); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported complainant personnel opened and used additional bd io needles from their inventory in an effort to determine whether the issue of the stylet not disengaging from the hub was procedural or device related.They were able to replicate the same failure mode in multiple new needles.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 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 device has not been received by the manufacturer for evaluation.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.
Event or Problem Description
Additional information: two devices were returned for investigation.This report addresses both 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 complaint of difficult obturator separation was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was four 25mm intraosseous (io) needles.Two of the samples were received with their opened packaging.The opened packages identified batch number bslc11463.Two samples were received in their original sealed packaging.These packages identified batch number bslc11212.Inspection of the two opened samples (samples 1 and 2) revealed the obturators to be misaligned within the needle shafts.No obvious use residues were observed.Removal of the obturators from the two sealed samples was successful and unremarkable.Removal of the rotated obturators was ultimately successful; however, resistance was encountered.During manipulation, the needle luers felt loose within the obturator hubs.Needle and obturator hub features were measured using a digital microscope and a top-down viewing angle.Those measurements were compared against the device specifications.Several dimensions were found to be outside of manufacturing specifications.The obturators were successfully removed from the needle shafts; however, the loose fit between the obturator and needle hubs can result in 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 products are supplied components and the supplier has been notified of this event and has made updates to the relevant molding equipment.The complaint samples were manufactured prior to those updates.The returned samples did not exhibit any use residues, suggesting that they may not have been the products used in the field and may belong to the cohort used for testing by the complainant facility.While components were found to be outside of manufacturing specifications, the extent to which these features contributed to the failure of resuscitation efforts is ultimately unknown.

• 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: 24122227
• Report Number: 3006260740-2026-00095
• Device Sequence Number: 21255207
• Product Code: FMI
• UDI-Device Identifier: 00801741163678
• UDI-Public: (01)00801741163678(11)250618(17)280618(10)BSLC11212
• 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): 04/08/2026

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: D015251NK
• Device Lot Number: BSLC11212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• 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