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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIO PROBE 7G; BIOPSY INSTRUMENT
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BARD PERIPHERAL VASCULAR, INC. ENCOR BIO PROBE 7G; BIOPSY INSTRUMENT Back to Search Results
Model Number ECP017G
Device Problems Material Fragmentation (1261); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2021
Event Type  malfunction  
Event Description
It was reported that during an ultrasound guided breast biopsy through fibroadenoma tissue, a black oily substance was allegedly found on the device.The procedure was completed with another surgical procedure.There was no reported patient injury.
 
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2023).Device pending return.
 
Event Description
It was reported that during an ultrasound guided breast biopsy through fibroadenoma tissue, a black oily substance was allegedly found on the device.The procedure was completed with another surgical procedure.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.One electronic photo was provided for review.Photo shows the needle with the aperture opened fully, where there was black substance at the aperture of the needle.Therefore, based on the photo review, the reported failure foreign material and material fragmentation can be confirmed based on the provided photo.Therefore, the investigation for the reported foreign material and material fragmentation is confirmed based on the provided photo.It is likely the black substance reported could be due to silicon and metal particulate; however a definitive root cause for the alleged device contamination with chemical or other material and material fragmentation could not be determined as the physical device was not returned.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 (expiry date: 06/2023), h11: h6 (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 : device not returned.
 
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Brand Name
ENCOR BIO PROBE 7G
Type of Device
BIOPSY INSTRUMENT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
INFUS MEDICAL (THAILAND)
706 moo 4
bangpoo ind estate
samutprakarn province 10280
TH   10280
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12982025
MDR Text Key282104349
Report Number2020394-2021-02065
Device Sequence Number1
Product Code KNW
UDI-Device Identifier00801741086281
UDI-Public(01)00801741086281
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K051158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberECP017G
Device Catalogue NumberECP017G
Device Lot NumberVTFT0342
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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