MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD PTFE FELT

Model Number	007959
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 7959 bard ptfe felt experienced a material split, cut or torn.Of this event, the device was used on the patient with no reported injury.The patient was a (b)(6) year-old male with weight not provided.The 7959 bard ptfe felt was not returned to the manufacturer limiting investigation.

• Brand Name: BARD PTFE FELT
• Common Device Name: PTFE FELT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8533458
• Report Number: 2020394-2019-00502
• Device Sequence Number: 1516035
• Product Code: DXZ
• UDI-Device Identifier: 00801741041297
• UDI-Public: (01)00801741041297
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

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: No Information
• Device Model Number: 007959
• Device Catalogue Number: 007959
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/19/2019
• Patient Sequence Number: 1