MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK; STAND, INFUSION

Catalog Number VPPDFP

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2022

Event Type  malfunction  

Event Description

During picc dressing change, experienced a faulty statlock (piece of statlock plastic broke off, and clasp of the statlock was unable to close).Picc line was heavily manipulated due to faulty statlock.Faulty statlock was removed and picc recleaned.New statlock placed w/o issue, dressing change completed w/o issue.X-ray was completed to confirm line placement prior to line use.Ok to use order given by crnp prior to picc use.Statlock ref vppdfp, statlock lot jugr1460, use by date 2025-04-28.

• Brand Name: STATLOCK
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 15454547
• MDR Text Key: 300242456
• Report Number: 15454547
• Device Sequence Number: 1
• Product Code: FOX
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: VPPDFP
• Device Lot Number: JUGR1460
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12045 DA
• Patient Sex: Female