MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC PORT ACCESS KIT 20G X 0.75IN 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)
Date of Event	02/20/2020
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 appeared to be supplier-related.The product returned for evaluation was one 20ga x 0.75¿ miniloc safety infusion set with non-valved y-site.Needleless injection caps were attached to both luer adapters.A longitudinally aligned crack was observed in the y-site, extending from the luer orifice.Microscopic inspection of the sample revealed a rough and granular fracture surface.The fracture propagated along a molding weld line in the material.The crack in the y-site occurred along a weld line feature introduced during the component molding process.Attempts to replicate the crack using non-complainant devices suggested that the crack occurred due to a combination of mechanical stress and cleaning chemical exposure at the site of the weld line.The complaint sample is a supplied component and the supplier has been notified of this event.Corrective actions are being investigated by the supplier and the complaint sample was manufactured prior to implementation of any corrective actions.A lot history review (lhr) of redx4854 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported patient returned to cancer infusion center with leaking miniloc.No other information provided.

• Brand Name: MINILOC PORT ACCESS KIT 20G X 0.75IN 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: 9824958
• Report Number: 3006260740-2020-00832
• Device Sequence Number: 3129881
• Product Code: FPA
• UDI-Device Identifier: 00801741044656
• UDI-Public: (01)00801741044656
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2020

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 Expiration Date: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 2682034
• Device Lot Number: REDX4854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1