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

Model Number MN1413

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

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

Event Date 12/24/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that during an ultrasound guided breast biopsy procedure through normal density tissue, the device needle allegedly bent.It was further reported that the device was allegedly difficult to be removed.Coaxial needle was used.The procedure was completed by using another device.There was no reported patient injury.

Event Description

It was reported that during an ultrasound guided breast biopsy procedure through normal density tissue, the device needle allegedly bent.It was further reported that the device was allegedly difficult to be removed.Coaxial needle was used.The procedure was completed by using another device.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one bard magnum biopsy needle was returned for evaluation.During visual evaluation, the device appeared to have blood residue and the device was received with the sample notch in exposed condition.On further evaluation, it was noted that sample notch appeared to be bent.Upon dimensional observation, sample notch thickness was within the specification and sample notch bend was not within the specification.Functional testing was not performed due to the condition of the device.Therefore, the investigation is confirmed for the reported bent needle issue, as the sample notch appeared to be bent.However, the investigation is inconclusive for the reported difficult to remove issue, as the reported conditions of use could not be replicated.A definitive root cause for the alleged bent needle and difficult to remove issue 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: g3, h6 (method).H11: h6 (result, conclusion).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.H3 other text : see h10.

• Brand Name: MAGNUM
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13302390
• MDR Text Key: 284198601
• Report Number: 2020394-2022-00015
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00801741084256
• UDI-Public: (01)00801741084256
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K934370
• 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,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MN1413
• Device Catalogue Number: MN1413
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• 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