MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TREK BONE MARROW BIOPSY KIT; BIOPSY INSTRUMENT

Catalog Number	TKM1110
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Obtain Sample (2533); Device-Device Incompatibility (2919); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent a bone marrow biopsy procedure; the doctor couldn't get out of the patient.The physician had to abort the procedure and start over because he couldn't get the ejector rod out of the ejector guide.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: section a through f ¿ the information provide by bd represents all 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: additional information was received, and the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.G3, h6 (device).Section a through f: the information provide by bd represents all 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
A patient underwent a bone marrow biopsy procedure, the doctor couldn't get out of the patient.The physician had to abort the procedure and start over because he couldn't get the ejector rod out of the ejector guide.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one trek biopsy cannula was received for evaluation; no anomalies were observed.On functional testing, an in-house quick connect hub was used for the following functional test.An attempt to load the received cannula to the in-house quick connect hub was performed.An audible click was heard and the cannula stayed in position within quick connect hub.An attempt to offload the cannula from the in-house quick connect hub was performed and was successful.No resistance was felt when the device was removed from the quick connect hub.Therefore, the investigation is inconclusive for the reported failure to obtain sample and device-device incompatibility as the incomplete setup was return for evaluation.A definitive root cause for the device-device incompatibility and failure to obtain sample could not be determined based upon the provided information.It is unknown whether patient and/or procedural issues contributed to the reported event.Labelling review: as the reported event did not allege a labelling or use related issue, a labelling review is not required.D4 (unique identifier (udi)#, g3, h6 (component, method).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
A patient underwent a bone marrow biopsy procedure, the doctor couldn't get out of the patient.The physician had to abort the procedure and start over because he couldn't get the ejector rod out of the ejector guide.There was no reported patient injury.

• Brand Name: TREK BONE MARROW BIOPSY KIT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CAREFUSION MANNFORD; 400 foster rd; mannford OK 74044
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22174486
• Report Number: 2020394-2025-00852
• Device Sequence Number: 12720053
• Product Code: KNW
• UDI-Device Identifier: 00801741201370
• UDI-Public: (01)00801741201370(11)250117(17)271231(10)0001605520
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K213896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2025

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 Catalogue Number: TKM1110
• Device Lot Number: 0001605520
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 10/18/2025; 11/28/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 10/30/2025; 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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
• Patient Sex: Female
• Patient Race: White