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

Model Number 007829

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2018

Event Type  malfunction  

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 Description

It was reported that during preparation for the procedure, there was allegedly foreign material found in the packaging.There was no patient contact.

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 Description

It was reported that during preparation for the procedure, there was allegedly foreign material found in the packaging.There was no patient contact.

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 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
• Type of Device: PTFE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8066911
• MDR Text Key: 127102154
• Report Number: 2020394-2018-02018
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 00801741041051
• UDI-Public: (01)00801741041051
• Combination Product (y/n): N
• PMA/PMN Number: K770835
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1