MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SENOMARK ULTRA BREAST TISSUE MARKER; BIOPSY INSTRUMENT

Model Number	SMEC10C
Medical Device Problem Codes	Device Slipped (1584); Component or Accessory Incompatibility (2897); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
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.The investigation of the reported event is currently underway.(expiry date: 06/2023).Device pending return.
Event or Problem Description
It was reported that prior to the marker placement procedure, the protecting clip was allegedly fell to the ground.The procedure was completed by using another device.There was no patient contact.
Event or Problem Description
It was reported that prior to the marker placement procedure, the protecting clip was allegedly fell to the ground.The procedure was completed by using another device.There was no patient contact.
Additional Manufacturer Narrative
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: one senomark ultra breast tissue marker applicator was returned for evaluation.During visual evaluation, the marker appeared to be clean and the applicator was returned with the marker deployed as the plunger was fully depressed.The wire-form and pva pads were not returned.Therefore, the investigation is inconclusive for the reported detachment of device or device component as the wire-form & pva pads were not returned and the investigation is inconclusive for the reported device slipped as the device was not received in a sealed package and also plunger was noted to be fully deployed.A definitive root cause for the alleged detachment of device or device component and device slipped 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: 06/2023), h11: h6 (method, 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 : see h10.
Event or Problem Description
It was reported that prior to the marker placement procedure, the protecting clip was allegedly fell to the ground.The procedure was completed by using another device.There was no patient contact.
Additional Manufacturer Narrative
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: one senomark ultra breast tissue marker applicator was received for evaluation.During visual evaluation, the marker appeared to be clean and the applicator was returned with the marker deployed as the plunger was fully depressed.The wire-form and pva pads were not returned.Therefore, the investigation is inconclusive for the reported component or accessory incompatibility and also the investigation is inconclusive for the reported device slipped as the device was not received in a sealed package, the wire-form & pva pads were not returned and also plunger was noted to be fully deployed.A definitive root cause for the alleged component or accessory incompatibility and device slipped 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: 06/2023), g3 h11: g1, h6 (device) 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: SENOMARK ULTRA BREAST TISSUE MARKER
• Common Device Name: 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12791972
• Report Number: 2020394-2021-01952
• Device Sequence Number: 5143398
• Product Code: NEU
• UDI-Device Identifier: 00801741032028
• UDI-Public: (01)00801741032028
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123911
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2022

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: SMEC10C
• Device Catalogue Number: SMEC10C
• Device Lot Number: VTET00313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 01/24/2022; 06/13/2022
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 01/27/2022; 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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