MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 19G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 0681934

Device Problem Activation Problem (4042)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of aserf010 showed two other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.

Event Description

It was reported that there were two needle stick injuries.It was stated when the needle is pulled and secured back into the safety lock, sometimes the tip will not completely retract into the device (even though it¿s lock).The nurses have stuck themselves because they assume the needle has been completely covered.It was further reported that three nurses have had needle sticks, two of which completed bloodwork themselves and also had the patient¿s blood tested for communicable diseases.One nurse declined bloodwork for her or the patient and declined reporting the event.This report addresses the third needle stick and the nurse who declined bloodwork.

• Brand Name: MINILOC SAFETY INFUSION SET 19G X 0.75IN WITH Y-SITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer Contact: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 10522442
• MDR Text Key: 206555007
• Report Number: 3006260740-2020-03234
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741048005
• UDI-Public: (01)00801741048005
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Catalogue Number: 0681934
• Device Lot Number: ASERF010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• 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