MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK IV SELECT MACRO 6IN SMARTSITE 25 BOX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2020
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 juer0524 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "iv0525 (statlock), we¿ve been ordering this item as sub/alternate since beginning of (b)(6) 2020.We¿ve been using a microclave item# mc100 for the needless connector end.Recently, we¿ve had a handful of accounts where connections have become disconnected.Nursing staff reported making sure all connections are secure, but we continue to experience disconnects.It has been noted that the i.V tubing with fluid is loose / disconnecting from the peripheral i.V extension , which has the microclave attached to it.It is not leaking or related to any pressure issues.It just seems to ¿ unwind ¿.We did not keep any of the affected lines.I do not have a confirmed number of how many times this was noted.This was reported by an rn , and an anesthesiologist, that they noticed the connections were loose.

• Brand Name: STATLOCK IV SELECT MACRO 6IN SMARTSITE 25 BOX
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10491429
• Report Number: 3006260740-2020-03156
• Device Sequence Number: 2567669
• Product Code: FPA
• UDI-Device Identifier: 00801741082016
• UDI-Public: (01)00801741082016
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K980992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: N/A
• Device Catalogue Number: IV0563
• Device Lot Number: JUER0524
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1