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 Codes	No Clinical Signs, Symptoms or Conditions (4582); Unintended Loss of Vascular Access (4867)
Date of Event	01/12/2026
Type of Reportable Event	Death
Event or Problem Description
Additional information provided 20-jan-2026: unfortunately, the inability to remove the stylet from the catheter delayed administration of critical resuscitative cardiac arrest medications.Iv access was attempted with no success.Io establishment was attempted.Numerous attempts were made to remove the stylet from the catheter once established in the patient¿s proximal tibia with no success.The providers were unable to dislodge the stylet from the catheter, causing significant delay and the inability to administer appropriate medication(s.) the significant delay of medication administration hindered the cardiac arrest resuscitation attempt.The patient was pronounced deceased at the emergency department after resuscitation attempt.
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.
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.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.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported that the entire io was coming out when they attempted to remove the needle.To their knowledge the io was placed correctly.The supervisor watched and no twisting was noticed upon attempting to remove the io stylet out.They ended up getting the io with ez io, distal tibia, 15mm.No further details available or provided.
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.
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 removal following needle placement was inconclusive because the returned products were unused and were therefore not the originally implicated/used device.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 slightly 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.These out of specification dimensions are addressed in trackwise complaint (b)(4).The returned samples were sealed, indicating they were not the products used in the field.While features of the returned samples were found to be outside of manufacturing specifications, it is unknown if the implicated device exhibited similar characteristics.It is further unknown if such features contributed to the reported event.Out of tolerance components may contribute to difficult obturator removal; however, insertion techniques have also been demonstrated to contribute.Those factors include inconsistent/excessive force applied while drilling and insertion at an oblique angle.The product ifu indicates that moderate, steady pressure at a 90-degree angle should be used during the insertion process.It further instructs the user to avoid rocking or bending during insertion.It is ultimately unknown if product features contributed to this reported event and to what extent difficult component separation may have contributed to the failure of resuscitation efforts.

• 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: 24164322
• Report Number: 3006260740-2026-00166
• Device Sequence Number: 21116744
• Product Code: FMI
• UDI-Device Identifier: 00801741163678
• UDI-Public: (01)00801741163678
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/15/2026

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: UNKNOWN
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 01/20/2026; 02/03/2026; 04/15/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 01/29/2026; 02/05/2026; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Death
• Patient Age: 14 DA
• Patient Sex: Unknown