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

Catalog Number 70S08C

Device Problem Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2023

Event Type  malfunction  

Event 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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 326295389
• Report Number: 2020394-2023-00932
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741021046
• UDI-Public: (01)00801741021046
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K004012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 70S08C
• Device Lot Number: VTES0045
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1