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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR DRIVER; REUSABLE BIOPSY
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BARD PERIPHERAL VASCULAR, INC. ENCOR DRIVER; REUSABLE BIOPSY Back to Search Results
Model Number DRENCOR
Device Problems Accessory Incompatible (1004); Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/26/2022
Event Type  malfunction  
Event Description
It was reported that during a breast biopsy procedure, the device is allegedly contaminated with blood.It was further reported that the device is not taking samples without pressing buttons.There was no reported patient injury.
 
Manufacturer Narrative
As the serial number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiration date: 12/2099.
 
Event Description
It was reported that during a breast biopsy procedure, the device is allegedly contaminated with blood.It was further reported that the device is not taking samples without pressing buttons.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: a device history record review and manufacturing review was not required as the event was determined to be expected and the investigation did not identify any manufacturing and/or service-related issues.Investigation summary: the encor driver was received for evaluation.The encor driver was visually inspected upon receipt and was found to be in good overall condition and functions normally.The sensor cover was scratched and upon disassembly, it was found that the device was contaminated with blood and the pcb on the control cable was contaminated and unable to be properly cleaned.The device was functionally tested and failed the tests due to failed initialization, so the calibration test and sample test were unable to be performed and motor 3 failed the motor voltage/encoder test and the motor power test.Upon disassembly, it was found that there was corrosion present on the front cb and the front cb failed the front cb test, with the green led #3 failing identified during evaluation.No other anomalies were identified.Therefore, the investigation is determined to be confirmed for the reported contamination issue and the investigation is determined to be confirmed for the identified initialization failure issue.The root cause for the reported contamination issue is unknown and the root cause for the identified initialization failure issue is unknown.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 12/2099), g3, h6 (device).H11: h6 (method, result, conclusion).H11: section a through f - the information provided by bd 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 bd.H3 other text : see h10.
 
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Brand Name
ENCOR DRIVER
Type of Device
REUSABLE BIOPSY
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
DYMAX CORP. -2523003
110 marshall drive
warrendale PA 15086
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key15656506
MDR Text Key302767957
Report Number2020394-2022-00832
Device Sequence Number1
Product Code KNW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDRENCOR
Device Catalogue NumberDRENCOR
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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