MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MONOPTY; BIOPSY INSTRUMENT

Catalog Number 211816

Device Problem Self-Activation or Keying (1557)

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

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2026) 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.

Event Description

It was reported that during an ultrasonic-guided biopsy procedure through normal density tissue, the physician turned the grip twice to set it, the inner needle allegedly shot out a little when it was set for second time and the device allegedly could not be able to collect tissue.No coaxial was used and the procedure was completed using another device.There was no reported patient injury.

• Brand Name: MONOPTY
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18786269
• MDR Text Key: 336323030
• Report Number: 2020394-2024-00274
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 211816
• Device Lot Number: REHR1107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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