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

Catalog Number	007828
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
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 was performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 during preparation for a surgical graft placement procedure, the packaging of the device was allegedly found to be unsealed.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 sealed sauvage filamentous knitted polyester fabric was received for evaluation.Upon visual evaluation, a tear was noted to the seal on the outer box.Sample 2 within the box was noted to be sealed and therefore not decontaminated.No other anomalies were observed.Therefore, the investigation is confirmed for the reported unsealed device packaging as a tear was noted to the seal on the outer box.A definitive root cause for the alleged unsealed device packaging issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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 during preparation for a surgical graft placement procedure, the packaging of the device was allegedly found to be unsealed.There was no patient contact.

• Brand Name: BARD SAUVAGE FILAMENTOUS KNITTED POLYESTER 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: 20006615
• Report Number: 2020394-2024-01246
• Device Sequence Number: 12570326
• Product Code: DXZ
• UDI-Device Identifier: 00801741041044
• UDI-Public: (01)00801741041044(11)231204(17)280928(10)HUHX1994
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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: 007828
• Device Lot Number: HUHX1994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• 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