MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT XK, 16 FR, ST, 23CM, STAND KIT; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5683730
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.(expiry date: 09/2020).
Event or Problem Description
It was reported that the covering that goes over the tunneler and the catheter prior to tunneling was allegedly split prior to use.Reportedly, a new device was used to complete the procedure.There was no patient contact.
Event or Problem Description
It was reported that the covering that goes over the tunneler and the catheter prior to tunneling was allegedly split prior to use.Reportedly, a new device was used to complete the procedure.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: a complaint lot history review was carried out for lot number.This is the first reported complaint for this lot number and this issue to date.Therefore, a device history record review is not required.Investigation summary: one hemosplit 23cm d/l catheter with a sheath on the catheter was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is confirmed for damaged tunneler sheath, as a partial longitudinal split approximately 3.3 cm in length was observed at the distal end of the tunneler sheath.The edges of the split appeared to be straight and the fracture surface appeared to be rough.The definitive root cause could not be determined based upon available information.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.

• Brand Name: HEMOSPLIT XK, 16 FR, ST, 23CM, STAND KIT
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8930905
• Report Number: 3006260740-2019-02500
• Device Sequence Number: 11294897
• Product Code: MSD
• UDI-Device Identifier: 00801741012730
• UDI-Public: (01)00801741012730
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K033294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 5683730
• Device Catalogue Number: 5683730
• Device Lot Number: REDN1438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 92