MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, and labeling.Based on a review of this information, the following was concluded: the complaint of loose particles within the luer adaptor was confirmed and the cause appeared to be supplier related.One 20g miniloc infusion set was returned for investigation.The infusion set was received with the blue cap attached to the luer adaptor.A microscopic examination of the luer adaptor revealed 12 blue particles within the luer adaptor.The largest particle was located at the entrance to the extension set tubing and was 3mm x 1.5mm.The thickness of the largest particle was measured with calipers and was found to be 0.05mm.All but the largest particle were clinging to the inner surface of the luer adaptor.Five particles were located between the stem of the blue cap and the inner surface of the luer adaptor.No blue particles were found along the length of the extension set tubing.No material appeared to be missing from the formed cap.It is possible that the material was flash from the injection molding process.Since the material appeared to be consistent with the blue cap, the supplier was notified of this complaint.A lot history review (lhr) of ascus0063 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "burrs in the miniloc." on 6/18/2019, per investigation small foreign particles were present in the returned device.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 0.75IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8777643
• Report Number: 3006260740-2019-01901
• Device Sequence Number: 19358513
• Product Code: FPA
• UDI-Device Identifier: 00801741048784
• UDI-Public: (01)00801741048784
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2019

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: S02020-75
• Device Lot Number: ASCUS0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1