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); Material Perforation (2205); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a bone marrow biopsy procedure, quick connect allegedly lost connection and disconnected from the needle.It was further reported that they allegedly had to manually twist/ pull the cannula out of the patient.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one quick connect hub, sterile sleeve and biopsy cannula were received for evaluation.During visual evaluation, it was noted that the biopsy stylet, needle grip, ejector rod, ejector guide and manual driver were not returned.On further observation, multiple perforations were noted to the sterile sleeve, stretching was noted to the sterile sleeve and the quick connect hub was x-rayed and it was noted that the distal uclip was found to be shifted slightly out of position.No other visual anomalies were noted to the device.Upon functional testing, resistance was felt when attaching and detaching the biopsy cannula from the quick connect hub/ sterile sleeve.No further functional testing was performed, due to the condition the sample was received.Therefore, the investigation is confirmed for the reported premature separation as distal uclip was found to be out of position, and this leads to the resistance observed while attaching and detaching the biopsy cannula from the quick connect hub.The investigation is also confirmed for identified material perforation as multiple perforation and stretching were noted on the sterile sleeve.However, the investigation is inconclusive for the reported difficult to remove as cause of the reported event cannot be replicated in the laboratory.A definitive root cause for the alleged premature separation issue is due to the distal-uclip which was found to be out of position.A definitive root cause for the reported difficult to remove and material perforation could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 02/2024).H11: section a through f ¿ the information provided 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.

• 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: 18814825
• Report Number: 2020394-2024-00286
• Device Sequence Number: 8170126
• Product Code: KNW
• UDI-Device Identifier: 00801741201370
• UDI-Public: (01)00801741201370
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/29/2024

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: 0001511895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 03/01/2024
• 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
• Patient Sex: Unknown