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

Catalog 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	11/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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.
Event or Problem Description
It was reported that prior to a vacuum assisted breast biopsy procedure, the lot number and expiration date on the box differs from the lot number and expiration date on the product.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records were reviewed, and the lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.A review of the product labeling was performed and found no product labeling inadequacies.The 1200cc hi-flow canister [1202san] is a supplied component repackaged and relabeled by bd.The physical canister displays information from the supplier (b)(4), while the product carton label contains details from bd.Therefore, the investigation is unconfirmed for the reported labeling issue.The definitive root cause for the reported event could not be determined.Labeling review: a review was performed of the product labeling and labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, unit label and manufacturing/assembly procedures).Per dc0702, canister-sccan01, the 1200cc hi-flow canister is manufactured and supplied by (b)(4) to covington manufacturing for packaging/repackaging product number 1202san.Per mp0300242 rev.05, senorx shipping pack sccan01 manufacturing procedure and per ip0300970 rev.03, shipping pack sccan01/2 finished product inspection procedure, the end item sccan01 contains a non-sterile 1200cc hi-flow canister set in a 12pack configuration.At this level, covington manufacturing takes a shipping box containing (b)(4) canister sets and converts to a 12pack configuration.Baw1461800 rev.01, label, carton, encor canister document provides a guide for on-demand permanent and variable print fields of the encor canister carton label.The product catalogue number, lot number and use-by date are variable fields manually typed by the covington operator and directly printed on the carton label by covington.The labeling review found no product labeling inadequacies.The physical canister displays information from the supplier (b)(4), while the product carton label contains details from bd.H10: g3, h6 (method, component).H11: h6 (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.
Event or Problem Description
It was reported that prior to a vacuum assisted breast biopsy procedure, the lot number and expiration date on the box differs from the lot number and expiration date on the product.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: 21032687
• Report Number: 2020394-2024-01916
• Device Sequence Number: 19863636
• Product Code: KNW
• UDI-Device Identifier: 10801741086691
• UDI-Public: (01)10801741086691(17)270201(10)VTJX0003
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K013641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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 Catalogue Number: SCCAN01
• Device Lot Number: VTJX0003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 12/29/2024
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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