MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC PORT ACCESS KIT 20G X 0.75IN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	2652034
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recn1042 showed one other similar product complaints from this lot number.(b)(4).
Event or Problem Description
It was reported that the chloraprep applicator was completely empty when it was removed from the port access kit during the placement procedure.No patient involvement.

• Brand Name: POWERLOC PORT ACCESS KIT 20G X 0.75IN
• 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: 7541049
• Report Number: 3006260740-2018-01089
• Device Sequence Number: 13511253
• Product Code: LJT
• UDI-Device Identifier: 00801741044472
• UDI-Public: (01)00801741044472
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2018
• Report Date (Section F): 05/02/2018

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: 2652034
• Device Catalogue Number: 2652034
• Device Lot Number: RECN1042
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1