MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD SAUVAGE FILAMENTOUS FABRIC; SAUVAGE FABRIC

Model Number	007829
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 09/2026).
Event or Problem Description
It was reported that prior to surgical graft implantation procedure, patch was allegedly found opened.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one bard sauvage filamentous knitted polyester fabric was returned for evaluation.Package was noted to be unsealed.No other anomalies noted to the sample.Therefore, the investigation is confirmed for the reported unsealed device packaging as the packaging was noted to be unsealed.One photo was provided and reviewed.The photo shows the device packaging.The packaging was noted to be unsealed and the based on the provided photo, the reported unsealed device packaging issue can be confirmed.A definitive root cause for the alleged unsealed device packaging issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Instructions for use precautions warns that the product is sterile unless the package is opened or damaged.Single use only.H10: d4 (expiry date: 09/2026), g3.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 surgical graft implantation procedure, patch was allegedly found opened.There was no patient contact.

• Brand Name: BARD SAUVAGE FILAMENTOUS FABRIC
• Common Device Name: SAUVAGE FABRIC
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15688929
• Report Number: 2020394-2022-00845
• Device Sequence Number: 20533377
• Product Code: DXZ
• UDI-Device Identifier: 00801741041051
• UDI-Public: (01)00801741041051
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K770835
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2023

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: 007829
• Device Catalogue Number: 007829
• Device Lot Number: HUFX0211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• 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