MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH® LONG-TERM HEMODIALYSIS CATHETER

Model Number	5393310
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was not provided, a review of the device history records has not been performed.The return of the device is pending.The investigation is currently underway.
Event or Problem Description
It was reported that allegedly the connecting piece from the stylet hub broke off.The component broke while prepping for procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during preparation for dialysis catheter insertion, the connecting piece from the stylet hub allegedly broke off.There was no patient contact.
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.Labeling review: as this complaint has been found to be manufacturing/supplier related, a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) is not applicable.Product labeling would not have prevented this issue.Investigation summary: one tunneler and one 31 cm glidepath were returned for evaluation.Gross visual and microscopic evaluations were performed.The investigation is confirmed for broken tunneler tip, as a broken tunneler tip was observed during sample evaluation.The break surfaces of the separated fragment and tunneler tip were smooth and uneven and mild surface damage was observed adjacent to the break.This is a known issue for glidepath tunnelers.The exact root cause for the damaged tunneler could not be determined.However, it is likely that supplier issues may have contributed to reported event.

• Brand Name: GLIDEPATH® LONG-TERM HEMODIALYSIS CATHETER
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8541901
• Report Number: 3006260740-2019-01131
• Device Sequence Number: 16751833
• Product Code: MSD
• UDI-Device Identifier: 00801741012204
• UDI-Public: (01)00801741012204
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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: 5393310
• Device Catalogue Number: 5393310
• Device Lot Number: RECX2705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 88