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

Model Number	007829
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer, however a photo was provided.The lot number for the device was provided.The device history records are currently under review.The sample was not returned to the manufacturer for inspection/evaluation.
Event or Problem Description
It was reported that during preparation for the procedure, there was allegedly foreign material found in the packaging.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: the device was returned for evaluation.The returned device had a brown foreign substance on the fabric.The investigation can be confirmed for foreign material present on the fabric.However, it is unknown when the foreign material came in contact with the fabric as the packaging was returned opened.Based upon the available information, the definitive root cause is unknown.It is unknown when the fabric became contaminated as it was returned with the packaging open.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.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 during preparation for the procedure, there was allegedly foreign material found in the packaging.There was no patient contact.
Additional Manufacturer Narrative
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: the device was returned for evaluation.Two electronic photos were also provided for review.Based on the photo review and evaluation of the returned sample, a brown foreign substance on the fabric could be identified.Therefore, the investigation can be confirmed for foreign material present on the fabric.However, it is unknown when the foreign material came in contact with the fabric as the packaging was returned opened.Based upon the available information, the definitive root cause is unknown.It is unknown when the fabric became contaminated as it was returned with the packaging open.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.
Event or Problem Description
It was reported that during preparation for the procedure, there was allegedly foreign material found in the packaging.There was no patient contact.

• Brand Name: BARD PTFE SAUVAGE FABRIC
• Common Device Name: PTFE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8066911
• Report Number: 2020394-2018-02018
• Device Sequence Number: 14058037
• Product Code: DXZ
• UDI-Device Identifier: 00801741041051
• UDI-Public: (01)00801741041051
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K770835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2019

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: HUBY0670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 06/14/2019; 07/11/2019
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 06/25/2019; 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1