MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BASIC KIT 18G X 10 CM WITH BIOPATCH; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	F318107T
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
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 remains in the patient.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 that after difficult midline placement with powerglide pro rt, upon removing the blood stopper, rn pulled back and blood that had collected in stopper flung into eyes.Rn went and washed eyes thoroughly and went to emergency department for blood work to be conducted.Waiting blood test results on patient and rn to see if there was exposure to anything significant.The sales rep stated blood test results are not available due to personal nature.To sales rep's knowledge, rn had no post exposure treatment.

• Brand Name: BASIC KIT 18G X 10 CM WITH BIOPATCH
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7791633
• Report Number: 3006260740-2018-02093
• Device Sequence Number: 16659307
• Product Code: FOZ
• UDI-Device Identifier: 00801741140518
• UDI-Public: (01)00801741140518
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• 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: F318107T
• Device Catalogue Number: F318107T
• 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: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1