MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK PICC PLUS CRESCENT SLIDING POST; STAND, INFUSION

Model Number N/A

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of jueq3708 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the clear plastic device came apart, where the device met the paper backing.No other information was provided.

Manufacturer Narrative

H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of jueq3708 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the clear plastic device came apart, where the device met the paper backing.No other information was provided.Medwatch rcvd (b)(6)2020 : the stabilizing body came apart from the adhesive pieces.This failure has come apart , out of the package and while a nurse attempted to install the device on a patient.

• Brand Name: STATLOCK PICC PLUS CRESCENT SLIDING POST
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10524779
• MDR Text Key: 206929191
• Report Number: 3006260740-2020-03249
• Device Sequence Number: 1
• Product Code: FOX
• UDI-Device Identifier: 00801741082948
• UDI-Public: (01)00801741082948
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

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: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: N/A
• Device Catalogue Number: PIC0220
• Device Lot Number: JUEQ3708
• Was Device Available for Evaluation?: No
• Event Location: Home
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1