MAUDE Adverse Event Report: BARD ACCESS SYSTEMS OTW, 14.5 FR, 23CM, ST, SPLIT TIP, STANDARD KIT; HEMODIALYSIS CATHETER

Model Number	5903230
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that prior to hemodialysis catheter placement, the tunneler tip broke off and was rendered unusable.It was further reported that another device was used to perform the procedure.There was no reported patient contact.
Event or Problem Description
It was reported that prior to hemodialysis catheter placement, the tunneler tip broke off and was rendered unusable.It was further reported that another device was used to perform the procedure.There was no reported patient contact.
Additional Manufacturer Narrative
Manufacturing review: a dhr review is not required, however it was requested.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 equistream d/l catheter along with tunneler, peel-apart sheath and dilator, and two additional dilators were returned for evaluation.Visual and microscopic evaluations were performed.The investigation is confirmed for damaged/defective tunneler, as the proximal portion of the plastic tip of the tunneler was observed to be broken off.The proximal fragment was not received with the sample.The break surface was observed to be smooth and uneven.The definitive root cause for the reported damaged tunneler issue could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.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: OTW, 14.5 FR, 23CM, ST, SPLIT TIP, STANDARD KIT
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8401477
• Report Number: 3006260740-2019-00486
• Device Sequence Number: 13558042
• Product Code: MSD
• UDI-Device Identifier: 00801741013706
• UDI-Public: (01)00801741013706
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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: 5903230
• Device Catalogue Number: 5903230
• Device Lot Number: RECX3053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1