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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of seventy-two for this event.H10: 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, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 05/2025).H11: section a through f ¿ the information provided by bd represents all 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: device pending return.
Event or Problem Description
It was reported that prior to a biopsy procedure, the device allegedly had a different product code labeled on the product itself.There was no patient contact.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: as this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of seventy-two for this event.H10: d4 (expiry date: 05/2025), g3 h11: section a through f: the information provide by bd represents all 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.Y-two for this event.H3 other text : device pending return.
Event or Problem Description
It was reported that prior to a biopsy procedure, the device allegedly had a different product code labeled on the product itself.There was no patient contact.

• Brand Name: ENCOR VACUUM CANISTER
• 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: 16938856
• Report Number: 2020394-2023-00339
• Device Sequence Number: 7451341
• Product Code: KNW
• UDI-Device Identifier: 10801741086691
• UDI-Public: (01)10801741086691
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K013641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

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: SCCAN01
• Device Catalogue Number: SCCAN01
• Device Lot Number: VTGW0002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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