MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MAXCORE DISPOSABLE CORE BIOPSY INSTRUMENTS

Catalog Number MC1820

Device Problems Failure to Prime (1492); Self-Activation or Keying (1557); Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that after the first biopsy sample was obtained, the slides were difficult to lock into place and the device fired on its own without being triggered.Another device was used to complete the procedure.There was no reported patient or user injury.

Manufacturer Narrative

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

Manufacturer Narrative

The lot number was not reported; therefore, the device history records could not be reviewed.The investigation is inconclusive, as the sample was not returned for evaluation.Per the reported event details, the device was dry fired prior to use.The instructions for use (ifu) states, "never test the product by firing into the air.Damage may occur to the needle/cannula tip." while a definitive root cause could not be determined based upon available information, dry firing of the device may have contributed to the reported event.The current ifu (instructions for use) states.Precautions.- never test the product by firing into the air.Damage may occur to the needle / cannula tip and could result in pt and / or user injury - unusual force applied to the stylet or unusual resistance against the stylet while extended out of the supportive cannula may cause the stylet to bend at the specimen notch.A bent specimen notch may interfere with the needle function.Directions for use: energize (cock) instrument by pulling back on the top slide to withdraw the cannula and lock in place.Then pull back on the bottom slide to withdraw the stylet and lock in place.Remove protective needle sheath and yellow guard.Instrument is ready to fire when both slides are locked back; verity instrument is energized (cocked).Note: do not place fingers in front of cocking slides once instrument is energized (cocked), impeding cocking slides' movement will impact functionality.

Manufacturer Narrative

To ensure compliance to 21 cfr 803.50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided.Multiple follow up attempts were made with the user facility to obtain any information pertaining to the patient, product, and/or procedural details (e.G.Date of the event, relevant test data, relevant history, lot #, catalog #, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation.The user facility did not have any additional details to provide at this time.Also, the file was documented with a health professional as a report source, but not reported.Corrected data: reports source (added).

• Brand Name: MAXCORE DISPOSABLE CORE BIOPSY INSTRUMENTS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 4055398
• MDR Text Key: 16563811
• Report Number: 2020394-2014-00361
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,health professional,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC1820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1