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

Model Number	5903190
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 19cm equistream d/l catheter, one stylet and one tunneler were returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is unconfirmed for damaged/defective catheter, as no anomalies/defects were identified in the catheter.However, the investigation is confirmed for broken tunneler tip, as a full break was identified in the plastic tip of the tunneler.The distal fragment of the tunneler plastic tip was found to be lodged in the distal end of the catheter venous lumen tip.The findings from the sample evaluation are consistent with fracture and material separation issues.The definite root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.(expiration date: 08/2020).
Event or Problem Description
It was reported that during dialysis catheter preparation, the tip on y connector allegedly broke off prior to use on patient.There was no patient contact.

• Brand Name: OTW, 14.5 FR, 19CM, ST, SPLIT TIP, STANDARD KIT
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10030424
• Report Number: 3006260740-2020-01674
• Device Sequence Number: 13644840
• Product Code: MSD
• UDI-Device Identifier: 00801741013690
• UDI-Public: (01)00801741013690
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K090101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/06/2020

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: RECZ3009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1