MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 INTRAOSSEOUS, INTRAOSSEOUS NEEDLE KITS

Catalog Number	D015451NK
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that they have experienced multiple issues involving difficulty removing the stylet from the io needle.The exact quantity of needles experiencing the reported issue was not provided.No further information has been 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.
Event or Problem Description
Additional information received on 6/25/2025: the customer was working a cardiac arrest on a 60-year-old male at a boat dock during a holiday weekend.They established io access in the right tibia, but when they attempted to remove the needle, it became stuck.Ultimately, the entire systems (needle and hub) had to be pulled from the patient¿s legs to resolve the issue.
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.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 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 returned to the manufacturer for evaluation.

• Brand Name: INTRAOSSEOUS, INTRAOSSEOUS NEEDLE KITS
• Common Device Name: INTRAOSSEOUS NEEDLE KITS
• 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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22078789
• Report Number: 3006260740-2025-03335
• Device Sequence Number: 9363159
• Product Code: FMI
• UDI-Device Identifier: 00801741163609
• UDI-Public: (01)00801741163609(11)241025(17)260407(10)BSLC7939
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/24/2025

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 Expiration Date: 04/07/2026
• Device Catalogue Number: D015451NK
• Device Lot Number: BSLC7939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2024
• 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: Required Intervention; Other
• Patient Age: 60 YR
• Patient Sex: Male