MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH LONG-TERM HEMODIALYSIS CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	5397230
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/23/2019
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 of the reported event is currently underway.
Event or Problem Description
It was reported that upon opening the chronic catheter kit, the white plastic tunneler tip was allegedly cracked.There was no reported patient contact.
Additional Manufacturer Narrative
Manufacturing review: a dhr review is not required, however it was requested.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.Investigation summary: one 14.5 fr d/l glidepath 23 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 the residual proximal catheter attachment stub of (7.75 to 8.02) mm length and detached stub tip of (4.09 to 4.71) mm length to the arrow head base and 3.14 mm width at the fracture end.Further examination showed the fracture break profiles to match up.The definitive root cause for the reported damaged tunneler issue could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.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.
Event or Problem Description
It was reported that upon opening the chronic catheter kit, the white plastic tunneler tip was allegedly cracked.There was no reported patient contact.

• Brand Name: GLIDEPATH LONG-TERM HEMODIALYSIS CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8372404
• Report Number: 3006260740-2019-00381
• Device Sequence Number: 16418408
• Product Code: MSD
• UDI-Device Identifier: 00801741012303
• UDI-Public: (01)00801741012303
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 03/31/2020
• Device Model Number: 5397230
• Device Catalogue Number: 5397230
• Device Lot Number: RECW0970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1