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

Model Number	864017D
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Additional 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, image was provided for review.The investigation of the reported event is currently underway.(expiration date: 07/2024).
Event or Problem Description
It was reported that during a breast tissue marker placement procedure under ultrasound guidance, the marker components were allegedly disassembled.There was no reported patient injury.
Event or Problem Description
It was reported that during a breast tissue marker placement procedure under ultrasound guidance, the marker components were allegedly misassembled.There was no reported patient injury.
Additional 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: only one device was involved in this reportable event at the user facility.Additional unused lot samples from the same lot/product catalog number were returned from the customer for evaluation and investigation of this event.The original device was not returned for evaluation.Two number of medical images were provided for review.Photograph shows the ml and cc views of the right breast.And it shows the photograph is taken immediately following an ultrasound -guided breast biopsy.It was noted that there was small metallic breast tissue marker in the upper outer right breast.Determination of shape of the marker cannot be concluded due to the low resolution of photograph.And it was noted that there was no abnormality to the tissue marker and it is easily visualized on the mammogram.On discussions, it was concluded that the last stage of ultrasound-guided biopsy is placement of tissue marker.It was noted that the photograph cant be a evidence for the alleged components misassembled condition.Based on the image review, mislabeled product cannot be confirmed based on the image provided as it cant be considered as evidence.Therefore, the investigation for the reported mislabeled product is kept as inconclusive as there was no proper evident provided.Three sealed ultraclip dual trigger breast tissue marker was returned for evaluation.On visual evaluation, it was opened and deployed.And it was noted that all the three samples had the correct marker deployed.Therefore, the investigation for the reported mislabeled product for the returned lot sample is unconfirmed.However, the investigation for the reported mislabeled product is kept as inconclusive as the original device was not returned.The catalog number provided indicates the product where only coil markers will be used, which may looked like a padlock marker from certain angles.However, a definitive root cause for the alleged mislabeled product 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 (expiration date: 07/2024), g3, h6 (method) 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.

• Brand Name: ULTRACLIP DUAL TRIGGER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15081467
• Report Number: 2020394-2022-00594
• Device Sequence Number: 5048584
• Product Code: NEU
• UDI-Device Identifier: 00801741032257
• UDI-Public: (01)00801741032257
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K090547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: 864017D
• Device Catalogue Number: 864017D
• Device Lot Number: HUFV0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown