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

Model Number MG1522

Device Problems Loose or Intermittent Connection (1371); Self-Activation or Keying (1557); Material Twisted/Bent (2981); Inadequate Lubrication (4057)

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

Event Date 10/28/2021

Event Type  malfunction  

Event Description

It was reported that the device auto fires after second cocking.There was no reported patient involvement.

Manufacturer Narrative

As the serial number for the device was provided, a review of the device history records 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: 07/2025).

Event Description

It was reported that prior to the biopsy procedure, the device allegedly auto fired after second cocking.There was no patient contact.

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 serial number was received.The magnum driver was visually inspected upon receipt and was found to be in a good condition, customer has engraved dianostic imaging 2021 on cover.Also, in latch plate assembly stylet catch spring is bent, the lower support plate of the latch plate assembly is also loose and device was found to be dry.The device was functionally tested and failed the tests due to failure of the latch plate assembly of the device.No other anomalies were identified.Therefore, the investigation is determined to be confirmed for the reported device auto fires after second cocking.The root cause determined to be the latch plate assembly, stylet catch spring is bent and the lower support plate of the latch plate assembly is also loose these factors causes to auto fire after second cocking.He investigation identified the following that would likely to have contributed to the reported event is device was dry this would be reason for self activation issue.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.Bd recommends the magnum instrument be cleaned and lubricated after every use to enhance the performance and longevity of the instrument.Silicone free, quality medical grade lubricant compatible with steam sterilization should be used to lubricate magnum instrument.Refer to the manufacturer's instruction to determine compatibility and for the use of the selected lubricating agent.Ensure all moving parts of the magnum instrument are lubricated.End - users may sterile the instrument after each cleaning and lubrication h10: d4 (expiry date: 07/2025), g3, h6 (device).H11: h6 (result, conclusion).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.H3 other text : see h10.

• 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: 12867368
• MDR Text Key: 281200088
• Report Number: 2020394-2021-01979
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741083945
• UDI-Public: (01)00801741083945
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K934371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• 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: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2021
• 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