MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 1.5IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 manufacturer has received the sample and will evaluate.Results are expected soon.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 when the device was received, the product was dirty inside the box.The device was not used on a patient.
Additional Manufacturer Narrative
The initial complaint appeared to be a reportable occurrence.Once the sample was returned the information provided does not reasonably suggest the event may have caused or contributed to a death or serious injury of a patient, user or other person.Therefore this event is deemed not reportable per 21 cfr part 803.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 when the device was received, the product was dirty inside the box.The device was not used on a patient.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 1.5IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7456241
• Report Number: 3006260740-2018-00799
• Device Sequence Number: 1121468
• Product Code: FPA
• UDI-Device Identifier: 00801741047558
• UDI-Public: (01)00801741047558
• 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
• Report Source: distributor
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

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: N/A
• Device Catalogue Number: 0632015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1