MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 7 FR. PTFE INTRO KIT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0601170
Medical Device Problem Codes	Defective Component (2292); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.This is the only complaint reported to date for this lot number and failure mode.Four introducer dilators and three introducer sheaths were returned for evaluation.All four dilator tips were observed to have damage, with one of the corresponding sheath tips having similar damage to that noted to its dilator tip.The investigation is confirmed for the reported introducer damage, specifically due to dilator tip damage.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 0601170 port & catheter, implanted, subcutaneous, intravascular allegedly kinked.This report was received from a single source.Of the one event, did involve patient with no reported patient injury.The patients age, weight and gender were not provided.

• Brand Name: 7 FR. PTFE INTRO KIT
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8532868
• Report Number: 3006260740-2019-01072
• Device Sequence Number: 11082161
• Product Code: DYB
• UDI-Device Identifier: 00801741038327
• UDI-Public: (01)00801741038327
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

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: No Information
• Device Model Number: 0601170
• Device Catalogue Number: 0601170
• Device Lot Number: REAV1055
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/19/2019
• Patient Sequence Number: 1