MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH 19CM ST EX KIT; LONG-TERM HEMODIALYSIS CATHETER

Model Number	5397190
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the tip of the tunneler allegedly broke off inside the catheter.Tip of the tunneler and the catheter was removed successfully from the patient.Reportedly, new device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during the dialysis catheter placement the tip of the tunneler allegedly broke off inside the catheter without migration.It was further reported that the tip of the tunneler and the catheter was removed successfully from the patient.Reportedly, new device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturer 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.Investigation summary: one glidepath 19cm catheter along with a tunneler in two segments 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.H11:section a through f - the information provided by bd 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 bd.

• Brand Name: GLIDEPATH 19CM ST EX KIT
• Common Device Name: LONG-TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8593453
• Report Number: 3006260740-2019-01308
• Device Sequence Number: 2339398
• Product Code: MSD
• UDI-Device Identifier: 00801741012297
• UDI-Public: (01)00801741012297
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 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: 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: 04/12/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 05/08/2019
• 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 Weight: 56