MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK IV SELECT MICRO 6IN SMARTSITE START KIT 50 BOX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number IVK0135

Device Problem Fluid/Blood Leak (1250)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of jucqx039 showed ten other similar product complaint(s) from this lot number.The complaints for this lot number (jucqx039) have been reported from the same facility.

Event Description

It was reported that the iv was successfully hand flushed with saline and with power injector for testing, but a small amount of contrast infiltrated into patient's arm during injection.A new device had to be placed by the ct tech.No patient injury was reported.

• Brand Name: STATLOCK IV SELECT MICRO 6IN SMARTSITE START KIT 50 BOX
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7792557
• MDR Text Key: 117587029
• Report Number: 3006260740-2018-02084
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741082535
• UDI-Public: (01)00801741082535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IVK0135
• Device Catalogue Number: IVK0135
• Device Lot Number: JUCQX039
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1