MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SENOMARK ULTRACOR MRI MARKER; BREAST TISSUE MARKER

Model Number	SMUCMRI14GSS
Medical Device Problem Codes	Component Missing (2306); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
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 the photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 12/2021).
Event or Problem Description
It was reported that prior to a biopsy procedure, the plastic spacer was allegedly missing and the length of the product was not accurate.The procedure was completed using another device.There was no patient contact.
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: the physical device was not returned for evaluation.Two photos were provided and reviewed.One photo shows the product labelling which verified with complaint.Another photo shows two markers, the alleged failure is for the device on the right hand side of the photo.The device was opened, and also the silica gel packet and tip protector are not included in the photo.Based on the photo review, the investigation is inconclusive for the reported failures as no objective evidence was provided and provided photos were not enough to confirm the event.A definitive root cause for the alleged component missing and device marking/labelling problem 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.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.
Event or Problem Description
It was reported that prior to a biopsy procedure, the plastic spacer was allegedly missing and the length of the product was not accurate.The procedure was completed using another device.There was no patient contact.

• Brand Name: SENOMARK ULTRACOR MRI MARKER
• Common Device Name: BREAST TISSUE MARKER
• 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 Key: 11840378
• Report Number: 2020394-2021-01058
• Device Sequence Number: 3425149
• Product Code: NEU
• UDI-Device Identifier: 00801741032141
• UDI-Public: (01)00801741032141
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050090
• 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): 12/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: SMUCMRI14GSS
• Device Catalogue Number: SMUCMRI14GSS
• Device Lot Number: VTEV00399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown