MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 22G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.[(b)(4)].
Event or Problem Description
It was reported via medwatch "infant pediatric patient access with a port-a-cath (pac) needle.Iv pump alarming downstream occlusion throughout the shift.The pac safety needle was retracting out of the port, requiring reinforcement of the needle underneath the dressing.This was causing stress and pain for the patient.".

• Brand Name: MINILOC SAFETY INFUSION SET 22G X 1 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8579286
• Report Number: 3006260740-2019-01278
• Device Sequence Number: 1836734
• Product Code: FPA
• UDI-Device Identifier: 00801741047589
• UDI-Public: (01)00801741047589
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2019
• Report Date (Section F): 04/17/2019

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: N/A
• Device Catalogue Number: 0632210
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/17/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 YR