MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT,14.5 FR,ST,19CM, STAND KIT; DIALYSIS CATHETER

Model Number	5703690
Medical Device Problem Codes	Difficult to Insert (1316); Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: the lot met all release criteria.Device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one tunneler, allegedly from a 14.5 fr d/l hemosplit 19 cm str hemodialysis catheter with surecuff kit, was returned for evaluation.Gross visual evaluation was performed.The investigation is inconclusive for difficulty to attach tunneler, as the catheter was not returned with the sample and the exact conditions at the time of the reported event are unknown.Additionally, the returned tunneler was compared to the engineering drawing of the correct tunneler for this kit.After comparison, it appeared that the returned tunneler is not the same as the correct.However, it is unknown whether the returned tunneler was originally in the sealed kit, as the sample was not returned in the original sealed packaging.Therefore, the investigation is inconclusive for incorrect tunneler found in packaging.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 (05/2021).
Event or Problem Description
It was reported that during dialysis catheter placement procedure, the catheter allegedly could not firmly attach with the tunneler for insertion.It was further reported that another tunneler was used and catheter was placed.There was no reported patient injury.

• Brand Name: HEMOSPLIT,14.5 FR,ST,19CM, STAND KIT
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8794653
• Report Number: 3006260740-2019-01963
• Device Sequence Number: 1876979
• Product Code: MSD
• UDI-Device Identifier: 00801741012884
• UDI-Public: (01)00801741012884
• Combination Product (Y/N): N
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 5703690
• Device Catalogue Number: 5703690
• Device Lot Number: RECS1056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial 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: 80