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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. TRUGUIDE DISPOSABLE BIOPSY NEEDLE BIOPSY INSTRUMENT Back to Search Results
Catalog Number C1820A
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 12/16/2016
Event Type  malfunction  
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 Description
It was reported that upon opening the five pack box, the box allegedly only contained three devices. There was no 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. 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 Description
It was reported that upon opening the five pack box, the box allegedly only contained three devices. There was no patient contact.
 
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Brand NameTRUGUIDE DISPOSABLE BIOPSY NEEDLE
Type of DeviceBIOPSY 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 Key6237380
MDR Text Key64354383
Report Number2020394-2016-01248
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K936194
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue NumberC1820A
Device Lot NumberREAP1790
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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