MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK IV SELECT MICRO 9IN BIFURCATED SMARTSITE 25 BOX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak in the extension tubing is confirmed but the exact cause remains unknown.Two extension sets with y sites from an iv select statlock kit were returned within opened packaging with lot: jucrx155.One sample was reutred with residual use material within the tubing.Both samples were flushed with water using a 12 ml syringe and both were observed to form beads of water at the distal end of the y site stem.Microscopic observation of the sample without the visible contaminants revealed a split in the extension tubing at the distal end of the ysite stem.The split was uneven and rough.Microscopic observation of the leak location on the second sample appeared to be a split in the extension tubing within the y site stem.Based on the damage observed, possible contributing factors include material fatigue due to kinking or excessive tensile force.Since the samples were observed to leak due to damage on the extension tubing, the complaint is confirmed but the exact cause remains unknown.A lot history review (lhr) of jucrx155 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (jucrx155) have been reported from the same facility.
Event or Problem Description
It was reported that the microbore extension sets are leaking at the y-site where the two lines split.It was stated this happened with two devices.This report addresses the second device.

• Brand Name: STATLOCK IV SELECT MICRO 9IN BIFURCATED 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: 8533361
• Report Number: 3006260740-2019-01104
• Device Sequence Number: 2431652
• Product Code: FPA
• UDI-Device Identifier: 00801741082061
• UDI-Public: (01)00801741082061
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

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: IV0566
• Device Lot Number: JUCRX155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1