MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK IV SELECT LUER RETAINER, SELECT PADS, STANDARD BORE 8 IN LUER LOCK EXTE; 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 juep1430 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by health professional "i personally witnessed a patient post op where the line had become disconnected.The perioperative staff have been informed to ensure that the connections are securely hand tightened." additional information received 8/19/2020: no patient harm reported.

• Brand Name: STATLOCK IV SELECT LUER RETAINER, SELECT PADS, STANDARD BORE 8 IN LUER LOCK EXTE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10491428
• Report Number: 3006260740-2020-03157
• Device Sequence Number: 14233136
• Product Code: FPA
• UDI-Device Identifier: 00801741081859
• UDI-Public: (01)00801741081859
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K980994
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: IV0525
• Device Lot Number: JUEP1430
• 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