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

Model Number	IVK0135
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the iv was started by the er in the left ac.The iv was tested by hand by the ct tech with 10 cc of saline followed by 30 cc @ 5 cc/sec with the contrast injector with no issues.During the first attempt of contrast injection the iv "fell apart." the ct tech reconnected the iv and test flushed with the injector again with no issues.The iv infiltrated approx.50 cc of contrast in the patient's left forearm.A new iv was placed in the patient's right arm for the third attempt, the ct tech test flushed with injector with no issues and the exam was successful.No patient injury was reported.

• Brand Name: STATLOCK IV SELECT MICRO 6IN SMARTSITE START KIT 50 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: 7792519
• Report Number: 3006260740-2018-02098
• Device Sequence Number: 2365944
• Product Code: FPA
• UDI-Device Identifier: 00801741082535
• UDI-Public: (01)00801741082535
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

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: IVK0135
• Device Catalogue Number: IVK0135
• Device Lot Number: JUCQX039
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 192