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	05/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a foreign material on a safety infusion set is confirmed; however, the cause is unknown.One 20 g x 1 in.Miniloc winged infusion set was returned for evaluation.An initial visual observation showed the sample was returned with the protective tubing on the needle and the blue dust cap on the luer connector hub.The dust cap was removed and a bright orange-red material was observed on the interior wall of the luer connector hub.A microscopic observation revealed the material was flat against the interior wall of the luer connector and the material itself was observed to be rough.When manipulated, the material was found to easily detach from the luer connector, and the material was observed to be elastic.The identity of the observed material is unknown and, because the sample was returned outside of its original and sealed packaging, it was not possible to determine when or where the sample came into contact with the foreign material.A lot history review (lhr) of ascss0228 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported a miniloc with red color at the tip.On (b)(6) 2019 - foreign material was found on the returned sample.

• 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: 8782788
• Report Number: 3006260740-2019-01925
• Device Sequence Number: 2338671
• Product Code: FPA
• UDI-Device Identifier: 00801741048722
• UDI-Public: (01)00801741048722
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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: S02020-10
• Device Lot Number: ASCSS0228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Event Location: Outpatient Diagnostic Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1