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

Model Number MG1522

Device Problems Break (1069); Self-Activation or Keying (1557); Difficult to Open or Close (2921)

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

Event Date 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

As the serial 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.(expiry date: 05/2023).Device pending return.

Event Description

It was reported that the device had a needle inside the breast which it fired itself, without pressing the trigger button, for which it is necessary to change the pistol to continue the biopsy.Also the device has physical deterioration, where the detachment of the load indicator is evident, and the door does not close properly.

Manufacturer Narrative

H10: manufacturing review: a device history record review and manufacturing review was not required as the event was determined to be expected and the investigation did not identify any manufacturing and/or service-related issues.Investigation summary: the magnum driver was received for evaluation.It was also found that sled position indicator assembly broken.The device was functionally tested and failed the test lid did not close properly.No other anomalies were identified.Therefore, investigation is determined to be confirmed for reported device self activation issue.The root cause was determined to be sled position indicator assembly broken which does not allow the lid to close properly.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: (expiry date: 05/2023).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 Description

It was reported that the device had a needle inside the breast which it fired itself, without pressing the trigger button, for which it is necessary to change the pistol to continue the biopsy.Also the device has physical deterioration, where the detachment of the load indicator is evident, and the door does not close properly.

• Brand Name: MAGNUM DRIVER
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): LAVELLE MACHINE; 485 groton road; westford 01886
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12653171
• MDR Text Key: 277135037
• Report Number: 2020394-2021-01882
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741083945
• UDI-Public: (01)00801741083945
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K934371
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MG1522
• Device Catalogue Number: MG1522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• 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: Reuse
• Patient Sequence Number: 1