MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (42CM); CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5834420
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that upon opening the package, the package was allegedly missing the tunneler.There was no reported patient contact.
Event or Problem Description
It was reported that upon opening the package, the package was allegedly missing the tunneler.There was no reported patient contact.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was performed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one hemostar hemodialysis catheter kit was returned for evaluation.The kit was returned opened and unsealed.The tunneler was not among the components returned.As the sample was returned opened and the original state of the package at the time of opening could not be confirmed, the investigation is inconclusive for the reported missing component.The root cause could not be determined based upon available information.It is unknown whether procedural factors contributed to the event.Potential contributing factors include misplacement of kit components after package opening and improper kit 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.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (42CM)
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8087765
• Report Number: 3006260740-2018-03280
• Device Sequence Number: 13786086
• Product Code: MSD
• UDI-Device Identifier: 00801741013461
• UDI-Public: (01)00801741013461
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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: 5834420
• Device Catalogue Number: 5834420
• Device Lot Number: REBZ1067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1