MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH® HEMODIALYSIS CATHETER; HEMODIALYSIS CATHERTER

Model Number	5397190
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
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 - one glidepath catheter kit.Returned was a glidepath catheter, inner stylet, two end caps, a dilator and a tunneler were returned for evaluation.A visual evaluation was performed.The investigation is inconclusive for missing component, as the sample was received with the components without packaging.No peel-apart sheath was received with the sample components.However, due to the components being returned without packaging it is unknown whether the missing components could have been lost in clinical or packaging return procedure.The definitive root cause could not be determined based upon available information.It is unknown if clinical, manufacturing, or return shipping procedure contributed to the reported 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.Expiry date (03/2020).
Event or Problem Description
It was reported that the peel-away sheath was allegedly missing from the product package.Therefore, another kit was opened and used to complete the procedure.There was no patient contact.

• Brand Name: GLIDEPATH® HEMODIALYSIS CATHETER
• Common Device Name: HEMODIALYSIS CATHERTER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8648155
• Report Number: 3006260740-2019-01487
• Device Sequence Number: 11248154
• Product Code: MSD
• UDI-Device Identifier: 00801741012297
• UDI-Public: (01)00801741012297
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Report Date (Section B): 05/28/2019

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: REDN0140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR