MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUGUIDE DISPOSABLE BIOPSY NEEDLE; BIOPSY INSTRUMENT

Catalog Number C2016B

Device Problems Fitting Problem (2183); Device Markings/Labelling Problem (2911); Device-Device Incompatibility (2919)

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

Event Date 04/20/2015

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.As the lot 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.The information provided by bard 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 bard.

Event Description

It was reported that after a successful ct-guided biopsy, the health care provider reported that the blunt tip stylet allegedly was not able to be inserted into the coaxial needle.No patient injury was reported.The procedure was completed successfully.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.This is the only complaint reported for this corporate lot number and issue to date.Visual/microscopic inspection: the sample and blunt tip stylet appeared to be clean.The sample was returned with the sharp tip stylet inside the cannula.The blunt tip stylet was not returned inside the cannula.There were no anomalies observed on the returned samples.Functional/performance evaluation: the stylet was untwisted from the cannula by hand without issues and the luer fittings on the device functioned correctly.Unsuccessful attempts were made to insert the blunt tip stylet through the cannula.Medical records review: medical records were not provided.Image/photo review: no images or photos were provided.Conclusion: the device was returned.The investigation is confirmed for device markings issue, as a 17g x 13.0cm blunt tip stylet was packaged in a 19g x 13.0cm truguide coaxial cannula needle package.The investigation is confirmed for device-device incompatibility, as the blunt tip stylet could not be inserted through the coaxial cannula.The root cause was determined to be manufacturing related, as the blunt tip stylet packaged with the truguide disposable coaxial biopsy needle was a 17g x 13.0cm stylet, when it should have been a 19g x 13.0cm stylet.Labeling review: the current truguide disposable coaxial instructions for use (ifu)provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.The information provided by bard 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 bard.

• Brand Name: TRUGUIDE DISPOSABLE BIOPSY NEEDLE
• Type of Device: BIOPSY INSTRUMENT
• 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: 5043803
• MDR Text Key: 25353105
• Report Number: 2020394-2015-01560
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K936194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: C2016B
• Device Lot Number: REXB1529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2013
• 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
• Patient Age: 68 YR