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

Model Number 864017DL

Device Problems Separation Failure (2547); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 09/2023).

Event Description

It was reported that during breast marker placement procedure under ultrasound guidance, the device allegedly had poor quality imaging.There was no reported patient injury.

Event Description

It was reported that during breast marker placement procedure under ultrasound guidance, the device allegedly had separation failure.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: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: two electronic photos were provided for review.Two photos represent the wireform present in the needle having blood residue on it.It shows the presence of wireform in the needle.Therefore, based on the photo review, the reported failure separation could not be confirmed based on the provided photo.Therefore, the investigation for the reported separation failure is kept as inconclusive as there was no proper evident provided.One ultraclip dual trigger was returned for evaluation.On visual evaluation, the device appeared to have blood residue and it was noted that the wireform was not returned.And it was further noted the needle was found to be bent and blunt.Due to the nature of the condition, functional evaluation cannot be done.Therefore, the investigation for the reported separation failure is kept as inconclusive as the functional evaluation is not done.A definitive root cause for the alleged separation failure could not be determined based upon the provided information.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: 09/2023),.

• Brand Name: ULTRACLIP DUAL TRIGGER
• Type of Device: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12237212
• MDR Text Key: 263845976
• Report Number: 2020394-2021-01403
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741032264
• UDI-Public: (01)00801741032264
• Combination Product (y/n): N
• PMA/PMN Number: K090547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 864017DL
• Device Catalogue Number: 864017DL
• Device Lot Number: HUEW2046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other