MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK CV PLUS SLIDING POST, TRICO HYDROCOLLOID CRESCENT PAD, 25 BOX; INTRAVASCULAR CATHETER SECUREMENT DEVICE

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of jucrx327 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the blue assembly could not be used normally, and then removed.
Additional Manufacturer Narrative
The initial complaint appeared to be a reportable occurrence.Upon receiving additional information, it was determined that a reportable event had not occurred.The initial complaint is a duplicate of another non-reportable complaint.
Event or Problem Description
It was reported that the blue assembly could not be used normally, and then removed.

• Brand Name: STATLOCK CV PLUS SLIDING POST, TRICO HYDROCOLLOID CRESCENT PAD, 25 BOX
• Common Device Name: INTRAVASCULAR CATHETER SECUREMENT DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8047649
• Report Number: 3006260740-2018-03168
• Device Sequence Number: 13905115
• Product Code: FOX
• UDI-Device Identifier: 00801741081552
• UDI-Public: (01)00801741081552
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 11/13/2018

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 Model Number: N/A
• Device Catalogue Number: CV0226
• Device Lot Number: JUCRX327
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1