MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 8 FR. PTFE INTRO KIT; IMPLANTABLE PORT & CATHETER ACCESSORIES

Model Number	0607780
Medical Device Problem Codes	Material Frayed (1262); Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one (1) malfunction event.A review of the event indicated that model 0607780 implantable port experienced a defective component.This event was reported from a single source.This event involved a patient with no reported injury.The patient¿s age, weight, and sex were not provided.
Event or Problem Description
This report summarizes one (1) malfunction event.A review of the event indicated that model 0607780 implantable port experienced a defective component.This event was reported from a single source.This event involved a patient with no reported injury.The patient¿s age, weight, and sex were not provided.
Additional Manufacturer Narrative
The lot number for the device was provided and the lot history review was performed.One j tip guidewire was returned for evaluation.Gross visual and microscopic visual evaluations were performed.The investigation is inconclusive for inability of guidewire to be removed from puncture catheter, as the guidewire was received without the puncture catheter.However, the investigation is confirmed for frayed/unraveled guidewire, as unraveling of the outer coil wire was observed near the distal tip and approximately 7.0cm from the proximal end.The definitive root cause could not be determined based upon available information.The device is labeled for single use.(device code: 1262 - material frayed).

• Brand Name: 8 FR. PTFE INTRO KIT
• Common Device Name: IMPLANTABLE PORT & CATHETER ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8532597
• Report Number: 3006260740-2019-01068
• Device Sequence Number: 1278254
• Product Code: DYB
• UDI-Device Identifier: 00801741038358
• UDI-Public: (01)00801741038358
• 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,Followup
• Report Date (Section B): 07/26/2019

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: 0607780
• Device Catalogue Number: 0607780
• Device Lot Number: REBU1769
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/26/2019
• Patient Sequence Number: 1