MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH 19CM ST EX KIT; DIALYSIS CATHETER

Model Number	5397190
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(expiration date: 07/2020).
Event or Problem Description
It was reported that the tunneler component that attaches to the dialysis catheter allegedly broke.There was no patient contact.
Event or Problem Description
It was reported that the tunneler component that attaches to the dialysis catheter allegedly broke.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 from a glidepath kit was 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 surface tunneler tip was smooth and uneven.The exact root cause for the damaged tunneler could not be determined.

• Brand Name: GLIDEPATH 19CM ST EX KIT
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8616211
• Report Number: 3006260740-2019-01400
• Device Sequence Number: 2010641
• Product Code: MSD
• UDI-Device Identifier: 00801741012297
• UDI-Public: (01)00801741012297
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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: 5397190
• Device Catalogue Number: 5397190
• Device Lot Number: RECZ1125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1