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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of juep1400 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the nurse noted that the plastic locking apparatus appeared to be separating from the adhesive strip when inspecting the dressing, a second device was required.Customer reported patient injury and medical intervention was required.It was further reported that the device migrated out of position and additional diagnostic testing was required to ensure the catheter could still be used.

• Brand Name: STATLOCK PICC PLUS CRESCENT SLIDING POST
• Common Device Name: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10436195
• Report Number: 3006260740-2020-03015
• Device Sequence Number: 4129022
• Product Code: FOX
• UDI-Device Identifier: 00801741082948
• UDI-Public: (01)00801741082948
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: PIC0220
• Device Lot Number: JUEP1400
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1