MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 8.0FR W/-4 VITACUFF PERC; CHRONIC CATHETER

Model Number	7711804
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.This is the only complaint reported to date for this lot number and failure mode.One 8fr groshong catheter was returned for evaluation.A microscopic and tactile evaluation were performed.The tissue cuff was noted to be detached from the catheter.Examination of the tissue cuff and catheter revealed use residue.Adhesive was observed at the 24cm depth marker.The adhesive was observed to be thorough, without any obvious voids.The tactile evaluation noted significant tensile weakness and necking adjacent to the adhesive section of the catheter and the proximal end of the catheter.Therefore, the investigation can be confirmed for the reported detached and/or defective tissue cuff.Per the evacuation results, significant tensile weakness and necking adjacent to the adhesive/cuff section of the catheter was noted.While a definitive root cause could not be determined based upon the available information, it is possible that procedural factors contributed to the reported event.Potential contributing factors include catheter and/or cuff manipulation prior to or during attempted use.It is unknown if patient factors may have also contributed to the reported event.The device is labeled for single use.
Event or Problem Description
This report summarizes one(1) malfunction event.A review of the events indicated that model 7711804 chronic catheter during catheter insertion, the cuff allegedly came off.It was further reported that the device replaced with another one.This report was received from one source.This event involved one female patient, (b)(6) years of age with no reported patient injury.

• Brand Name: 8.0FR W/-4 VITACUFF PERC
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8532598
• Report Number: 3006260740-2019-01065
• Device Sequence Number: 19211260
• Product Code: LJS
• UDI-Device Identifier: 00801741036767
• UDI-Public: (01)00801741036767
• 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: 7711804
• Device Catalogue Number: 7711804
• Device Lot Number: RECX1619
• 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