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

Catalog Number TKL1106

Device Problems Component or Accessory Incompatibility (2897); Device Contamination with Chemical or Other Material (2944); Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: received one connect hub for evaluation.Upon visual evaluation, the residue was noted on the release arm and on the sterile sleeve.The device appeared to have black residue in the inner side of the connect hub.There were no visual anomalies noted on the device.And, it was noted that the proximal u-clip was not present within the quick connect hub.Upon x-ray observation, the u-clips were rotated out of position.Two electronic photos were provided and it were reviewed.The first and second provided photos shows a quick connect hub and their sterile sleeve.Based on the photo review, the reported failure cannot be confirmed.Therefore, based on the sample evaluation, the whole investigation is inconclusive for the reported component or accessory incompatibility issue as the packaging tray was not returned & further functional testing was not performed.The investigation is confirmed for the reported premature separation issue as the device was received with u-clips out of position.And, the investigation is confirmed for the identified device contamination with chemical or other material issue as the black residue was noted in the inner side of the connect hub.A definitive root cause for the alleged premature separation issue was due to the u-clip placement (e.G., slightly out of position).Then, definitive root cause for the remaining reported component or accessory incompatibility and identified device contamination with chemical or other material issues 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: 01/2024).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.H3 other text : see h10.

Event Description

It was reported that during a bone lesion biopsy procedure via very dense or sclerotic lesion, allegedly putting quick connect in that was an issue and the tray was allegedly wobbly.It was further reported that the bag cover has to be opened quite wide to make sure the bag doesn¿t get in the way of the connector when the driver and the quick connect actually engage.Furthermore, after four passes, the quick connect allegedly popped off.There was no reported patient injury.

• Brand Name: TREK BONE LESION BIOPSY KIT
• Type of Device: 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: 18290523
• MDR Text Key: 330138225
• Report Number: 2020394-2023-01179
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TKL1106
• Device Lot Number: 0001507176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male