MAUDE Adverse Event Report: BARD ACCESS SYSTEMS S/L PER 8FR 65D; CHRONIC CATHETER

Model Number	7711800
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that the cuff of a chronic catheter allegedly fell off the catheter.It was further reported that a new device was placed.There was no reported patient injury.
Event or Problem Description
It was reported that the cuff of a chronic catheter allegedly fell off the catheter.It was further reported that a new device was placed.There was no reported patient injury.
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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one 8fr single lumen groshong catheter with surecuff tissue ingrowth cuff was returned for evaluation.The cuff was received detached from the catheter.Adhesive was observed on the catheter at the 24cm depth marker.No gaps could be seen in the adhesive on the catheter.During tactile evaluation, necking and tensile weakness of the catheter were observed at and near the region of the adhesive.No anomalies were noted to the cuff.Based on the findings, the investigation is confirmed for the reported cuff detachment.Per the evaluation results, necking and tensile weakness of the catheter were noted at and near the region of the adhesive.As such, it's possible that the mechanical properties of the catheter at the time of use contributed to the reported event.However, the definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.Potential contributing factors include chemical degradation, material fatigue and excessive force applied to the cuff.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• Brand Name: S/L PER 8FR 65D
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8095694
• Report Number: 3006260740-2018-03343
• Device Sequence Number: 19531094
• Product Code: LJS
• UDI-Device Identifier: 00801741036743
• UDI-Public: (01)00801741036743
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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 Expiration Date: 04/30/2023
• Device Model Number: 7711800
• Device Catalogue Number: 7711800
• Device Lot Number: RECS0721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 73