MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-SCRUB IPA; PAD, ALCOHOL, DEVICE DISINFECTANT

Catalog Number	3882025
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, as the device was discarded after the event occurred.A lot history review (lhr) of jubuf238 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported to the sales rep that during a clabsi eradication training, the foam fingers detached from the sitescrub.It was stated that when used on the open hub of a 3french power picc, it left fibers and bits of foam on the hub.This was not used on a patient as it was during training.

• Brand Name: SITE-SCRUB IPA
• Common Device Name: PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7068450
• Report Number: 3006260740-2017-02143
• Device Sequence Number: 16394979
• Product Code: LKB
• UDI-Device Identifier: 10801741086936
• UDI-Public: (01)10801741086936
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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 Catalogue Number: 3882025
• Device Lot Number: JUBUF238
• 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: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1