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

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/03/2020
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 foreign material is confirmed; however, the exact cause is unknown.Two photographs of a 20 g miniloc infusion set were returned for evaluation.An initial visual observation of the photographs showed a black residue on or possibly within the tubing of the infusion set, about midway between the needle housing and the luer hub.The pinch clamp on the tubing was observed to be engaged, and no obvious evidence of use was observed on the sample in the returned photographs.It is unknown when or where the alleged sample may have come into contact with the black residue observed on the sample in the returned photographs.Possible causes include contamination of the sample during manufacture or before or after sealing of the packaging.A lot history review (lhr) of asdps0084 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the miniloc needle had a black substance in the tubing.

• 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: 10138854
• Report Number: 3006260740-2020-02030
• Device Sequence Number: 14361751
• 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: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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 Expiration Date: 01/28/2022
• Device Model Number: N/A
• Device Catalogue Number: S02020-10
• Device Lot Number: ASDPS0084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Event Location: Outpatient Diagnostic Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1