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

Model Number	SMEC10C
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Remove (1528)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Of the three devices, two lot numbers were provided and lot history reviews were performed.Of the three devices, product catalog no for one device was unk senomark.Of the three devices, one device was returned to the manufacturer for evaluation, and the evaluation inconclusive for failure to deploy and difficult to remove.For the remaining two malfunctions, the investigation is inconclusive for failure to deploy and difficult to remove.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model smec10c biopsy instrument allegedly experienced positioning failure and difficult to remove.This information was received from various sources.This malfunction involved all three patients with no consequences.One (b)(6) year old female patient weight was not provided.The remaining two patients age, sex and weight were not provided.
Additional Manufacturer Narrative
H10: of the three devices, two lot numbers were provided and lot history reviews were performed.Of the three devices, product catalog no for one device was unk senomark.Of the three devices, one device was returned to the manufacturer for evaluation, and the investigation is inconclusive for failure to deploy issue;but unconfirmed for the alleged difficult remove.For the remaining two malfunctions, the investigation is inconclusive for failure to deploy and difficult to remove.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.H10: g4 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.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model smec10c biopsy instrument allegedly experienced positioning failure and difficult to remove.This information was received from various sources.This malfunction involved all three patients with no consequences.One 50 year old female patient weight was not provided.The remaining two patients age, sex and weight were not provided.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model smec10r biopsy instrument allegedly experienced positioning failure and difficult to remove.This information was received from various sources.This malfunction involved all three patients with no consequences.One patient was 50 years old.Two patients were reported as female.All other patient details were not provided.
Additional Manufacturer Narrative
H10: of the three devices, two lot numbers were provided and lot history reviews were performed.Of the three devices, product catalog no for one device was unk senomark and another was ecp0110g.Of the three devices, one device was returned to the manufacturer for evaluation, and the investigation is inconclusive for failure to deploy issue;but unconfirmed for the alleged difficult remove.For the remaining two malfunctions, the investigation is inconclusive for failure to deploy and difficult to remove.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.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 MARKER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10749035
• Report Number: 2020394-2020-06175
• Device Sequence Number: 11627329
• Product Code: NEU
• UDI-Device Identifier: 00801741032028
• UDI-Public: (01)00801741032028
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2021

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: No Information
• Device Model Number: SMEC10C
• Device Catalogue Number: SMEC10R
• Device Lot Number: VTDW0641, VTDU00471, UNKNOWN
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020; 06/30/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 01/14/2021; 07/22/2021
• Patient Sequence Number: 1