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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a leak in the extension set tubing was inconclusive since the damage could not be verified from the two photographs that were provided for investigation.The photos showed an extension set with a y-injection site.The extension set matched the component from product code (b)(4)" macro ext.No leak or damage to the tubing could be discerned from the photographs; therefore, the complaint was inconclusive and the cause of the reported damage was unknown.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported the nurse experienced a leaking iv catheter tubing in the middle of caring for a critically ill adult.It is stated there appeared to be a leak from a hole in the tubing in the location where the clamp had been on the tubing.

• Brand Name: STATLOCK IV SELECT MACRO 6IN SMARTSITE Y AND VALVE 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: 9916786
• Report Number: 3006260740-2020-01141
• Device Sequence Number: 2732189
• Product Code: FPA
• UDI-Device Identifier: 00801741082047
• UDI-Public: (01)00801741082047
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/02/2020

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 Model Number: N/A
• Device Catalogue Number: IV0564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1