MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. STATLOCK PICC PLUS STABLIZATION DEVICE; INTRODUCER, CATHETER

Catalog Number VPPCSP

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Event Description

Staff member noted second occurrence that statlock picc plus catheter stabilization device is very difficult to slide the blue posts into holes on picc.Posts seem stuck.Statlock put aside and different one used.No harm to patients.

• Brand Name: STATLOCK PICC PLUS STABLIZATION DEVICE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 9255181
• MDR Text Key: 164288072
• Report Number: 9255181
• Device Sequence Number: 1
• Product Code: DYB
• 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: 10/15/2019

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
• Device Operator: No Information
• Device Catalogue Number: VPPCSP
• Device Lot Number: JUDRF497
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1