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

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
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 that 35mm needle not separating after insertion.This was a typical insertion.Nothing was abnormal during the insertion process.The drill worked perfectly, and insertion was on the patient's tibia.There was no patient harm.The needles were used 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 difficult obturator removal was confirmed; however, the precise root cause was not identified.The product returned for evaluation was one 35mm intraosseous (io) needle.The obturator was inlaid through the needle shaft.Light usage residues were visible in the needle bevel.Both the needle and obturator tips exhibited deformation.The obturator appeared to be oriented incorrectly within the needle shaft.Microscopic inspection of the io needle confirmed deformation of both the needle and obturator tips.The obturator was confirmed to be twisted within the needle shaft.The edges of both the needle and obturator flared outward in a twisted shape.Attempts to remove the obturator were unsuccessful due to the incorrect orientation within the needle shaft.The difficulty removing the obturator was caused by the obturator being oriented incorrectly within the needle shaft.Such twisting may occur if the obturator is not properly seated within the needle during drilling efforts and if the obturator is initially inserted incorrectly.It could not be determined which occurred in this instance.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.

• Brand Name: INTRAOSSEOUS, INTRAOSSEOUS NEEDLE KITS
• Common Device Name: INTRAOSSEOUS, 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 UT 84116
• Manufacturer Contact: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22347822
• Report Number: 3006260740-2025-04362
• Device Sequence Number: 4901602
• Product Code: FMI
• UDI-Device Identifier: 00801741163593
• UDI-Public: (01)00801741163593(11)250316(17)260812(10)BSLC9485
• 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): 09/02/2025

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 Expiration Date: 08/12/2026
• Device Model Number: N/A
• Device Catalogue Number: D015351NK
• Device Lot Number: BSLC9485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2025
• 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