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

Model Number MN1410

Device Problem Material Twisted/Bent (2981)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 02/2024).Device not returned.

Event Description

It was reported that during a breast biopsy procedure, the needle was allegedly bent.It was further reported that there were a delay in the procedure, trauma, pain, bleeding.The current patient status is unknown.

Event Description

It was reported that during an ultrasound guided breast biopsy procedure through hard tissue, the needle was allegedly bent.It was further reported that there were a delay in the procedure, trauma, pain, bleeding.A coaxial needle was not used and the procedure was completed using the same device.The current patient status is unknown.

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 serious injury.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: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the alleged material twisted / 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.(expiry date: 02/2024) 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 : device not returned.

• Brand Name: MAGNUM
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12517681
• MDR Text Key: 272862072
• Report Number: 2020394-2021-01790
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00801741084249
• UDI-Public: (01)00801741084249
• Combination Product (y/n): N
• PMA/PMN Number: K934370
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MN1410
• Device Catalogue Number: MN1410
• Device Lot Number: REFQ1982
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR