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

Model Number	007837
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.
Event or Problem Description
It was reported that upon opening the device package, a foreign material was allegedly identified on the surface of the device.There was no patient contact.
Event or Problem Description
It was reported that upon opening the device package, a foreign material was allegedly identified on the surface of the device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a dhr review was requested to review manufacturing records due to the nature of the complaint.The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate that there was a manufacturing related cause for this event.Investigation summary: one bard ptfe felt was returned for review.A stain was noted on the bottom portion of the outer package (tyvek).Therefore, the investigation is confirmed for foreign material present in device.It is possible that the alleged contamination occurred during shipping and handling or at the user facility.It cannot be confirmed that this contamination is manufacturing related.Based upon the available information, the definitive root cause is unknown.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.

• Brand Name: BARD PTFE FELT
• Common Device Name: PTFE FELT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; lot #1, road #3, km 79.7; tempe AZ 85281
• MDR Report Key: 8081959
• Report Number: 2020394-2018-02051
• Device Sequence Number: 243815
• Product Code: DXZ
• UDI-Device Identifier: 00801741000195
• UDI-Public: (01)00801741000195
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 01/29/2020

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: 007837
• Device Catalogue Number: 007837
• Device Lot Number: HUCP1632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1