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

Model Number	5397190
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during preparation of the insertion procedure while attempting to attach the tunneler component to the dialysis catheter, the plastic piece on the tunneler broke off.There was no patient contact.
Event or Problem Description
It was reported that during preparation of the insertion procedure while attempting to attach the tunneler component to the dialysis catheter, the plastic piece on the tunneler broke off.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: manufacturing records were reviewed (dhr, mrr¿s, scrap and mfg.Process changes) and there were not found evidence that the failure mode reported in this complaint is caused by the mfg.Process.Investigation summary: based on the sample evaluation: one 14.5 fr d/l glidepath 19 cm str hemodialysis catheter with surecuff kit was returned for evaluation.Visual and microscopic evaluations were performed.The investigation is confirmed for damaged/defective tunneler, as a break was noted on connecter of tunneler.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.Vt-sca-19-4398 has been issued to turnxon precision co.Ltd to address the damaged tunneler issue and identify appropriate actions.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.(expiry date: 07/2020).

• 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: 8592293
• Report Number: 3006260740-2019-01295
• Device Sequence Number: 2193095
• Product Code: MSD
• UDI-Device Identifier: 00801741012297
• UDI-Public: (01)00801741012297
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/19/2019

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: 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: 04/26/2019
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/25/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1