MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD MAX-CORE DISPOSABLE BIOPSY INSTRUMENT

Model Number MC1410

Device Problems Failure to Prime (1492); Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 05/2023).

Event Description

It was reported that during an ultrasound-guided breast biopsy through normal density tissue, the device allegedly failed to prime.A coaxial needle was not used.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during an ultrasound-guided breast biopsy through normal density tissue, the device allegedly failed to prime.A coaxial needle was not used.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: 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.H10: d4 (expiry date: 05/2023), 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.

• Brand Name: BARD MAX-CORE DISPOSABLE BIOPSY INSTRUMENT
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11553017
• MDR Text Key: 241998342
• Report Number: 2020394-2021-00635
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741084423
• UDI-Public: (01)00801741084423
• Combination Product (y/n): N
• PMA/PMN Number: K133948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC1410
• Device Catalogue Number: MC1410
• Device Lot Number: REET1224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other