• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACLIP DUAL TRIGGER BREAST TISSUE MARKER; BIOPSY INSTRUMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. ULTRACLIP DUAL TRIGGER BREAST TISSUE MARKER; BIOPSY INSTRUMENT Back to Search Results
Model Number 863017DL
Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 01/2022).Device not returned.
 
Event Description
It was reported during a mammogram guided breast marker placement procedure, the clip allegedly did not deployed.It was further noticed that the clip fell inside the packet.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.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.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the alleged device slipped could not be determined based upon the provided information.Labeling review: instructions for use included with this product family prescribes the proper method of implantation for this device to prevent undue injury to the patient and damage to the product.H10: d4 (expiry date: 01/2022).H11: section a through f ¿ the information provide by bd represents all 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.
 
Event Description
It was reported during a mammogram guided breast marker placement procedure, the clip allegedly did not deploy.It was further noticed that the clip fell inside the packet.The procedure was completed using another device.There was no reported patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ULTRACLIP DUAL TRIGGER BREAST TISSUE MARKER
Type of Device
BIOPSY INSTRUMENT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key12292370
MDR Text Key265543874
Report Number2020394-2021-01434
Device Sequence Number1
Product Code NEU
UDI-Device Identifier00801741032240
UDI-Public(01)00801741032240
Combination Product (y/n)N
PMA/PMN Number
K042341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/10/2021
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
Device Operator Health Professional
Device Model Number863017DL
Device Catalogue Number863017DL
Device Lot NumberHUCZ2038
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/13/2021
Initial Date FDA Received08/09/2021
Supplement Dates Manufacturer Received08/09/2021
Supplement Dates FDA Received08/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-