MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. STATLOCK; TAPE AND BANDAGE, ADHESIVE

Catalog Number VPPCSP

Device Problems Disconnection (1171); Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2019

Event Type  malfunction  

Event Description

Upon patient's arrival (infant / toddler) to dialysis care taker reports the plastic unit of the statlock stabilization device (plastic part of unit that locks onto hd cvc wings) had completely disconnected from the crescent foam pad of device.The foam pad of the device remained on the patient's chest.It was noted the patient's hemodialysis catheter had migrated out of his chest with cuff of catheter exposed.Securement device was not effective in securing the hemodialysis catheter.

• Brand Name: STATLOCK
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 8991539
• MDR Text Key: 157413412
• Report Number: 8991539
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: VPPCSP
• Device Lot Number: JUDNF110
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 730 DA
• Patient Weight: 11