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
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: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 09/2028) 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 electronic photo was provided and reviewed.The photo shows one outer packaging of the sauvage fiber.A tear was noted to the seal on the outer box.Based on the photo review the reported event can be confirmed.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 1 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.

• 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: 20014516
• Report Number: 2020394-2024-01244
• Device Sequence Number: 11855669
• 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: 08/21/2024
• 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