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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling (2091)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of jucqx015 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the patient experience swelling and blistering in her arm.No other information available at this time.

• Brand Name: STATLOCK DIALYSIS CLAMSHELL RETAINER ON TRICOT HYDROCOLLOID BUTTERFLY PAD
• Type of Device: INTRAVASCULAR CATHETER SECUREMENT DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 8057209
• MDR Text Key: 127074450
• Report Number: 3006260740-2018-03191
• Device Sequence Number: 1
• Product Code: FOX
• UDI-Device Identifier: 00801741081644
• UDI-Public: (01)00801741081644
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DI0120CE
• Device Lot Number: JUCQX015
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1