MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of asbus0197 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that in the production line, 1 unit of needle miniloc lot asbus0197 presented some fluid/liquid in the tube.The unit was segregated, identified and forwarded for shipment to the manufacturer.
Event or Problem Description
It was reported that in the production line, 1 unit of needle miniloc lot asbus0197 presented some fluid/liquid in the tube.The unit was segregated, identified and forwarded for shipment to the manufacturer.
Additional Manufacturer Narrative
Section a through f - the initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred.

• Brand Name: MINILOC SAFETY INFUSION SET 20G 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: 8142062
• Report Number: 3006260740-2018-03495
• Device Sequence Number: 1407376
• Product Code: FPA
• UDI-Device Identifier: 00801741048722
• UDI-Public: (01)00801741048722
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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: Other
• Device Model Number: N/A
• Device Catalogue Number: S02020-10
• Device Lot Number: ASBUS0197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Event Location: Other
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1