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

Model Number	MC1810
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ultrasound guided lymph biopsy procedure, the tip of needle was allegedly broken.A coaxial needle was not used.There was no reported patient injury.
Additional 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: 06/2023).
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 maxcore disposable core biopsy instrument was returned for evaluation.On visual evaluation, the device appeared clean and the device was received in a condition where both the slides were in their initial positions.On further evaluation, the top slide was pulled back to examine the sample notch, the bent was noted to the sample notch and the bent was backwards.On dimensional observations, the bent was not within the specified limits.(i.E out of specification limit).Due to the nature of the complaint, functional evaluation was not conducted.Therefore, the investigation for the reported break is unconfirmed as there was no breakage identified to the device.However, the investigation of the identified needle bent is confirmed as the bent was noted and it was noted to be in the out of specification limit.A definitive root cause for the alleged break and identified needle bent could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 06/2023).H11: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
It was reported that during an ultrasound guided lymph biopsy procedure, the tip of needle was allegedly broken.A coaxial needle was not used.There was no reported patient injury.

• Brand Name: MAXCORE
• Common Device Name: 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13647220
• Report Number: 2020394-2022-00134
• Device Sequence Number: 2304794
• Product Code: KNW
• UDI-Device Identifier: 00801741084461
• UDI-Public: (01)00801741084461
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133948
• 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,Followup
• Report Date (Section B): 03/31/2022

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 Model Number: MC1810
• Device Catalogue Number: MC1810
• Device Lot Number: REEU1262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 04/05/2022
• 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