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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
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 that admin staff opened two needles at the main station resulting in failures.I had them describe to me the technique used for insertion, and they did state they pulled straight up on all.The needles are twisted inside of the shaft and will not come apart, except when using pliers to force them apart.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.
Event or Problem Description
It was reported that admin staff opened a needle at the main station resulting in failure.I had them describe to me the technique used for insertion, and they did state they pulled straight up.The needles was twisted inside of the shaft and would not come apart, except when using pliers to force them apart.
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 a stuck stylet/obturator is confirmed; however, the exact cause is unknown.Two photographs and one video of an io needle were returned for evaluation.An initial visual observation of the photographs and video showed the needle with a stylet/obturator installed.Some slight use residue was observed on the needle cannula.The obturator appeared slightly over-clocked within the needle cannula, and there appeared to be some damage to the needle tip; however, this could not be clearly discerned from the returned photographs and video.One of the photos and the video showed the stylet/obturator slightly removed from the needle.While the obturator of the device appeared to be positioned in such a way that it would be difficult to remove, there were no distinguishing features in the returned photographs and video of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.

• 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 UT 84116
• Manufacturer Contact: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24639600
• Report Number: 3006260740-2026-01765
• Device Sequence Number: 15954675
• Product Code: FMI
• UDI-Device Identifier: 00801741163678
• UDI-Public: (01)00801741163678(11)250418(17)260920(10)BSLC9575
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 04/23/2026

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 Expiration Date: 09/20/2026
• Device Model Number: N/A
• Device Catalogue Number: D015251NK
• Device Lot Number: BSLC9575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 04/23/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/03/2026; 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2025
• 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