MAUDE Adverse Event Report: BARD ACCESS SYSTEMS OTW, 14.5 FR, 19CM, ST, SPLIT TIP, STANDARD KIT; LONG-TERM HEMODIALYSIS CATHETER

Model Number	5903190
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 is not available for return, however a photo was provided for review.The investigation is currently underway.(expiry date: 07/2020).
Event or Problem Description
It was reported that during preparation a piece of the catheter allegedly detached.Reportedly, a new kit was opened to completed the procedure.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.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 that has been reported for this corporate lot number to date.Investigation summary: one electronic photo of a split tip catheter and tunneler was returned for evaluation.A photo review was performed.The investigation is inconclusive for damaged/defective catheter, as the photo captured only a part of the catheter and no obvious damage or defects were visible on the catheter.However, the investigation is conclusive for damaged/defective tunneler, as a broken tunneler tip was observed in the returned photo.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.Corrective action has been issued to turnxon precision co.Ltd to address the damaged tunneler issue and identify appropriate actions.Labeling review: as this complaint has been found to be manufacturing/supplier related, a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) is not applicable.Product labeling would not have prevented this issue.(expiry date: 07/2020).
Event or Problem Description
It was reported that during preparation a piece of the catheter allegedly detached.Reportedly, a new kit was opened to completed the procedure.There was no patient contact.

• Brand Name: OTW, 14.5 FR, 19CM, ST, SPLIT TIP, STANDARD 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: 8604354
• Report Number: 3006260740-2019-01363
• Device Sequence Number: 2359597
• Product Code: MSD
• UDI-Device Identifier: 00801741013690
• UDI-Public: (01)00801741013690
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090101
• 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): 05/22/2019

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: 5903190
• Device Catalogue Number: 5903190
• Device Lot Number: RECZ0716
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1