MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET STANDARD KIT (14; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5393350
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or 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.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the catheter placed femorally was sutured in; however, the catheter has fallen out of the patient.
Additional Manufacturer Narrative
It was also identified that the fda rn number was incorrect and the correct fda rn number (b)(4).This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.Manufacturing review: per the lot history review, this is the first complaint reported for this lot number and general issue to date.Based upon the severity level and lot quantity, a dhr review is not required.Received 2 complaints reported for this lot number to date.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate investigation summary: one glidepath 35 cm d/l catheter with surecuff was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The surecuff showed residue (e.G.Blood residue) throughout the cuff; however, one region of the surecuff has substantially more residue than another region.There is a distinct border on one side of the cuff between the regions with an inclined profile.These observations are consistent with characteristics of the cuff not being completely surrounded by tissue.There are sutures tied in both suture wing holes and another suture on the catheter between the suture wings and the surecuff.The investigation is inconclusive for catheter dislodgement as the circumstances of the patient¿s medical environment at the time of and prior to the reported event are unknown.The definitive root cause could not be determined based upon available information.However, it is unknown if patient and/or procedural issues contributed to the reported event.Expiration date: 08/2019.
Event or Problem Description
It was reported that the dialysis catheter which was placed in the femoral site and sutured in, had allegedly fallen out.There was no reported patient injury.

• Brand Name: GLIDEPATH LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET STANDARD KIT (14
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7485580
• Report Number: 2020394-2018-00556
• Device Sequence Number: 1716706
• Product Code: MSD
• UDI-Device Identifier: 00801741012211
• UDI-Public: (01)00801741012211
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

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 Model Number: 5393350
• Device Catalogue Number: 5393350
• Device Lot Number: REBZ1072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1