MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SM VEN ATTACH PLAS PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0602650
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Based on the evaluation: one m.R.I.Implantable port, 6.6 fr single lumen catheter basic kit was returned for evaluation.A visual evaluation was performed.The investigation is inconclusive for missing component, as the sample was receive with the tray and outer packaging with a hickman silicone catheter, mri implantable port, straight non coring needle, two vein pics, a flushing connector, and a catheter lock.There was no visible right angle non coring needle was enclosed.However, due to the kit being returned opened upon return it is unknown whether the missing components could have been lost in clinical or packaging return procedure.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 0602650 port & catheter, implanted, subcutaneous, intravascular was allegedly missing an item.This report was received from a single source.The one event did not involve a patient.The patients age, weight and gender were not provided.

• Brand Name: SM VEN ATTACH PLAS PORT
• 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: 8532862
• Report Number: 3006260740-2019-01074
• Device Sequence Number: 13845729
• Product Code: LJT
• UDI-Device Identifier: 00801741025648
• UDI-Public: (01)00801741025648
• 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: 0602650
• Device Catalogue Number: 0602650
• Device Lot Number: REZI1646
• 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