MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR VACUUM CANISTER; BIOPSY INSTRUMENT

Model Number	SCCAN01
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the two malfunctions was provided and a lot history review was performed.The device has not been returned for evaluation, therefore, the investigation is inconclusive for device markings or labelling problem as no objective evidence has been provided to confirm any alleged deficiency with the device.A photo was provided for investigation, but is a photo of a different lot and does not provide any additional information to the malfunction.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model sccan01 biopsy instrument allegedly experienced a device markings issue.This information was received from various sources.Of the two malfunctions, no patients were involved and as such the age, weight, and gender of the intended patient¿s was not provided.
Additional Manufacturer Narrative
H10: the lot number for the two malfunctions was provided and a lot history review was performed.The devices for both malfunction has not been returned for evaluation, however, one photo for each malfunction was provided.A photo for one malfunction is provided from a different lot and does not provide any additional information to the malfunction.One photo was provided for another malfunction, however, the investigation for this malfunction is currently underway.Based upon the available information, the definitive root cause is unknown.The device is 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.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model sccan01 biopsy instrument allegedly experienced a device markings issue.This information was received from various sources.Of the two malfunctions, no patients were involved and as such the age, weight, and gender of the intended patient¿s was not provided.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model sccan01 biopsy instrument allegedly experienced a device markings issue.This information was received from various sources.Of the two malfunctions, no patients were involved and as such the age, weight, and gender of the intended patient¿s was not provided.
Additional Manufacturer Narrative
H10: the lot number for the two malfunctions were provided and a lot history review was performed.The devices for both malfunctions have not been returned for evaluation, however, one photo for each malfunction was provided.A photo for one malfunction was provided from a different lot and does not provide any additional information to the malfunction.One photo was provided for another malfunction, however, the investigation unconfirmed for both the reported mislabeled product issue.A definitive root cause could not be determined.The device was 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: ENCOR VACUUM CANISTER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9205692
• Report Number: 2020394-2019-04079
• Device Sequence Number: 19492859
• Product Code: KNW
• UDI-Device Identifier: 10801741086691
• UDI-Public: (01)10801741086691
• 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): 07/07/2020

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: SCCAN01
• Device Catalogue Number: SCCAN01
• Device Lot Number: VTCR0002
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019; 06/30/2020
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 01/07/2020; 07/07/2020
• Patient Sequence Number: 1