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

Catalog Number	C1820A
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently under way.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 or Problem Description
It was reported that upon opening the five pack box, the box allegedly only contained three devices.There was no patient contact.
Additional 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.The lot met all release criteria.Visual/microscopic inspection: as the sample was not returned for evaluation, a visual/microscopic inspection could not be performed.Functional/performance evaluation: as the sample was not returned for evaluation, a functional/performance evaluation could not be performed.Medical records review: no medical records were provided; therefore, a medical record review could not be performed.Image/photo review: no images or photos were provided; therefore, a medical record review could not be performed.Conclusion: a sales review, a complete dhr review, and inventory assessment were completed for this complaint.The investigation was inconclusive, as the sample was not returned for evaluation and the additional investigation activities could not confirm the reported event.Per the sales review, it was noted that the facility purchases various truguide coaxial cannulas including the alleged catalog c1820a.All purchases made were in multiples of 5.As the truguide is sold in cartons of 5 devices each, it was unlikely that the facility received an odd number of devices in a carton.Additionally, reconciliation at the manufacturing site indicates that all materials used in the manufacturing of this lot were documented and accounted for.Therefore, it was unlikely that the issue was manufacturing related.Lastly, repacking of this device was not performed at the global distribution center.Therefore, it was unlikely that this issue was caused during the distribution of this lot.Based on the available information, the definitive root cause was unknown.Labeling review: the current ifu (instructions for use) states: general information and device description: the bard truguide disposable coaxial biopsy needle is a three part device consisting of an outer cannula with an attached female luer-style lock hub, an inner stylet with an attached male luer-style lock hub, and a flexible slip ring style depth stop.Precautions: before using, inspect the needle for damaged point, bent shaft or other imperfections that would prevent proper function.If the needle components are damaged or bent, do not use.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 or Problem Description
It was reported that upon opening the five pack box, the box allegedly only contained three devices.There was no patient contact.

• Brand Name: TRUGUIDE DISPOSABLE BIOPSY NEEDLE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6237380
• Report Number: 2020394-2016-01248
• Device Sequence Number: 651532
• Product Code: FCG
• UDI-Device Identifier: 00801741085055
• UDI-Public: (01)00801741085055(17)190228(10)REAP1790
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K936194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: C1820A
• Device Lot Number: REAP1790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1