MAUDE Adverse Event Report: BARD ACCESS SYSTEMS L/P TI CHRFX ATT 6FR DAI; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0605550
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Manufacturing records were reviewed and there were not found evidence that the failure mode reported in this complaint is caused by the manufacturing process.A sample evaluation could not be performed as the samples were not returned.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Possible contributing factors include defective introducer, insufficient design( eg.Dimensions); however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).The investigation is inconclusive due to the fact that no sample was returned for evaluation.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 605550 port & catheter allegedly had defective components.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient was reported to be a (b)(6) male whose age was not provided.

• Brand Name: L/P TI CHRFX ATT 6FR DAI
• 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: 8800160
• Report Number: 3006260740-2019-01991
• Device Sequence Number: 16921460
• Product Code: LJT
• UDI-Device Identifier: 00801741025976
• UDI-Public: (01)00801741025976
• 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): 07/17/2019

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: 0605550
• Device Catalogue Number: 0605550
• Device Lot Number: RECW1405
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/17/2019
• Patient Sequence Number: 1