MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ALLPOINTS PORT ACCESS SYSTEM 20 G X 1 IN.; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	AN142010G
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/15/2018
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, as the device was discarded after the event occurred.A lot history review (lhr) of rebz0666 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the nurse opened up a brand new allpoints port access kit and found a human hair underneath the guardiva patch.No patient involvement.

• Brand Name: ALLPOINTS PORT ACCESS SYSTEM 20 G X 1 IN.
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7567527
• Report Number: 3006260740-2018-01216
• Device Sequence Number: 16584193
• Product Code: FPA
• UDI-Device Identifier: 00801741119323
• UDI-Public: (01)00801741119323
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K073050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

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: AN142010G
• Device Catalogue Number: AN142010G
• Device Lot Number: REBZ0666
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1