MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUGUIDE COAXIAL BIOPSY INSTRUMENT

Catalog Number C1816B

Device Problems Device Markings/Labelling Problem (2911); Packaging Problem (3007)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2016

Event Type  malfunction  

Manufacturer Narrative

Only one sample was involved in this event at the user facility.An additional 14 unopened sealed lot samples from the same lot were returned from the customer for evaluation and investigation of this event.As the lot number was provided, a review of the device history record is currently being performed.And 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 prior to unpackaging the device in preparation for a biopsy procedure, the health care provider (hcp) identified two blunt needles in the package, instead of one blunt needle, one sharp needle, and coaxial.Reportedly, the hcp identified additional devices with a similar issue from the same lot while preparing for this procedure.There was no reported patient contact.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: the samples were returned sealed in their original packaging.It was noted that 6 of the sealed packages contained two trocar tip stylets inside of two coaxial cannulas.The remaining 9 sealed packages contained two blunt tip stylets without coaxial cannulas.All 15 returned packages contained a depth stopper.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: 15 sealed samples were returned.The investigation is confirmed for device markings issue, as the incorrect packaging contents were included in all 15 returned samples.The root cause was determined to be manufacturing related, as the incorrect contents were packaged inside of the 15 returned samples.6 of the sealed packages contained two trocar tip stylets inside of two coaxial cannulas.The remaining 9 sealed packages contained two blunt tip stylets without coaxial cannulas.All 15 returned packages contained a depth stopper.The correct packaging contents should be: one trocar tip stylet inserted into one coaxial cannula, a blunt tip stylet, and a depth stopper.Labeling review: the current 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.

Event Description

It was reported that prior to unpackaging the device in preparation for a biopsy procedure, the health care provider (hcp) identified that some packages contained two sharp trocar stylets inside of two coaxial needles and other packages contained two blunt tip stylets, instead of one blunt tip stylet, one sharp trocar stylet, and one coaxial.Reportedly, the hcp identified additional devices with a similar issue from the same lot while preparing for this procedure.There was no reported patient contact.

• Brand Name: TRUGUIDE COAXIAL BIOPSY INSTRUMENT
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 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 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5563601
• MDR Text Key: 42940831
• Report Number: 2020394-2016-00341
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K936194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: C1816B
• Device Lot Number: REZK0479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2015
• 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