MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK CV PLUS, PEDIATRIC, SLIDING POST, PIGTAIL RETAINER 25BX; CATHETER SECUREMENT DEVICE

Catalog Number	VCDPP
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2016
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 juarf693 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that two days after placement of the device, the retainer was detached from the pad.No patient injury reported.

• Brand Name: STATLOCK CV PLUS, PEDIATRIC, SLIDING POST, PIGTAIL RETAINER 25BX
• Common Device Name: CATHETER SECUREMENT DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6226842
• Report Number: 3006260740-2017-00001
• Device Sequence Number: 709823
• Product Code: KMK
• UDI-Device Identifier: 00801741083136
• UDI-Public: (01)00801741083136(17)190331(10)JUARF693
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/12/2016

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: 03/31/2019
• Device Catalogue Number: VCDPP
• Device Lot Number: JUARF693
• 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: 01/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1