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

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a cracked y-site was confirmed and the cause was supplier-related.The product returned for evaluation was one 20ga x 1¿ miniloc safety infusion set.Usage residues were observed throughout the sample and the safety mechanism was engaged.A longitudinally aligned split was observed in the y-site.Microscopic inspection of the split revealed a granular fracture surface.Discoloration and abundant superficial stress cracking were observed in the vicinity of the split.The split propagated along a molding weld line.The split propagated along a molding feature, indicating that features created during the molding process caused the observed fracturing.The stress fracturing observed further suggested that some part of the manufacturing process affected the mechanical properties of the y-site material.The device is a supplied component and the supplier has been notified of this event.A lot history review (lhr) of aserf029 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "the patient called the unit stating that his pump was leaking, upon arrival the closest hub to the patient was crusted with 5fu.We removed the needle and re accessed the patient.He came back to the unit 24 hours later to have his pump disconnected" tm reported "cracked y-site at" hospital.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 1 IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10395497
• Report Number: 3006260740-2020-02897
• Device Sequence Number: 2744066
• Product Code: FPA
• UDI-Device Identifier: 00801741048029
• UDI-Public: (01)00801741048029
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2020

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 Model Number: N/A
• Device Catalogue Number: 0682010
• Device Lot Number: ASERF029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1