MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK DIALYSIS CLAMSHELL RETAINER ON TRICOT HYDROCOLLOID BUTTERFLY PAD; INTRAVASCULAR CATHETER SECUREMENT DEVICE

Catalog Number	DI0120
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 juasf406 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (juasf406 ) have been reported from the same facility.
Event or Problem Description
It was reported that the statlock allegedly popped open and the patient could not close it.This report addresses the second statlock that the patient had.No patient injury reported.

• Brand Name: STATLOCK DIALYSIS CLAMSHELL RETAINER ON TRICOT HYDROCOLLOID BUTTERFLY PAD
• Common Device Name: INTRAVASCULAR CATHETER SECUREMENT DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5954565
• Report Number: 3006260740-2016-00491
• Device Sequence Number: 839717
• Product Code: KMK
• UDI-Device Identifier: 00801741081637
• UDI-Public: (01)00801741081637(17)190430(10)JUASF406
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2016

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 Expiration Date: 04/30/2019
• Device Catalogue Number: DI0120
• Device Lot Number: JUASF406
• Was Device Available for Evaluation?: No
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1