MAUDE Adverse Event Report: C.R. BARD, INC. STATLOCK PICC PLUS; STAND, INFUSION

Catalog Number PIC0222

Device Problems Defective Device (2588); Activation Failure (3270)

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

Event Date 09/22/2022

Event Type  malfunction  

Event Description

As per report, "patient was in clinic for picc line dressing change.When trying to snap the wing down on the left side of the stat lock it would not click.Tried more pressure and it would still not click in.Had to get another one which worked perfectly.Defective stat lock." manufacturer response for statlock picc plus, (brand not provided) (per site reporter) sales rep reported issue to manufacturer.Bd requested additional information and return of product for follow-up.

• Brand Name: STATLOCK PICC PLUS
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 16093867
• MDR Text Key: 306627719
• Report Number: 16093867
• 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: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PIC0222
• Device Lot Number: JUFW0689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1