MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. IMPRA VASCULAR GRAFT; EPTFE VASCULAR GRAFT

Catalog Number	70S08C
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a surgical graft placement procedure, the expiration date in the quality certificate was allegedly found to be different than the expiration date in the actual product package.There was no patient contact.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 05/2025).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.
Event or Problem Description
It was reported that prior to a surgical graft placement procedure, the expiration date in the quality certificate was allegedly found to be different than the expiration date in the actual product package.There was no patient contact.
Additional Manufacturer Narrative
H10: additional information was received and based on the review, the issue was noticed at bd regional distribution center, and has not been sold to any customers.Since a complaint is any communication that alleges deficiencies of product outside of bd control; therefore, this report is no longer being considered a complaint file and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.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.Device not returned.

• Brand Name: IMPRA VASCULAR GRAFT
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17987131
• Report Number: 2020394-2023-00932
• Device Sequence Number: 8199533
• Product Code: DSY
• UDI-Device Identifier: 00801741021046
• UDI-Public: (01)00801741021046
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K004012
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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 Catalogue Number: 70S08C
• Device Lot Number: VTES0045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 10/31/2023
• 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