MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK CV PLUS SLIDING POST, TRICO HYDROCOLLOID CRESCENT PAD, 25 BOX; 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)
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 judy2115 showed six other similar product complaint(s) from this lot number.The complaints for this lot number (judy2115) have been reported from the same facility in (b)(4).
Event or Problem Description
It was reported that there has been an increase in the number of safety reports related to the plastic piece of the statlock detaching from the adhesive backing.No other information was provided.It was further reported that this occurred with 7 devices, four of which were returned to manufacturer.This report addresses the fifth device.

• Brand Name: STATLOCK CV PLUS SLIDING POST, TRICO HYDROCOLLOID CRESCENT PAD, 25 BOX
• Common Device Name: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10906992
• Report Number: 3006260740-2020-03590
• Device Sequence Number: 14173544
• Product Code: FOX
• UDI-Device Identifier: 00801741081552
• UDI-Public: (01)00801741081552
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

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: 11/28/2022
• Device Model Number: N/A
• Device Catalogue Number: CV0226
• Device Lot Number: JUDY2115
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1