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

Model Number	N/A
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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a cracked connector is confirmed; however, the exact cause is unknown.One 20 g x ¾¿ miniloc with y-site was returned for evaluation.An initial visual observation showed both clamps are not engaged, needle was observed to be bent, luer cap was connected to the proximal luer, safety was not engaged, and no obvious evidence of use.Sample was flushed and pressurized with a 12ml syringe of water from both the proximal and distal connectors; no leaks were observed.A microscopic observation revealed superficial fractures on exterior and interior of the luer of the y-site.No complete cracks were observed either luer connector.An iso luer taper gage was inserted into the y-site luer connector.Luer connector was found to be within specification.While no leakage was observed, superficial fractures were observed in the luer connector of the y-site.The exact cause of the fracturing in the luer connector hub is unknown; however, possible contributing factors include forceful insertion of a tapered object into the orifice of the luer hub, environmental conditions, and over-tightening of the connector.A lot history review (lhr) of asdnf033 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the proximal access port cracked and leaked fluoricil on the patient.No harm to patient.

• Brand Name: MINILOC SAFETY INFUSION SET 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: 8757459
• Report Number: 3006260740-2019-01860
• Device Sequence Number: 2637641
• Product Code: FPA
• UDI-Device Identifier: 00801741048043
• UDI-Public: (01)00801741048043
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2019

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: 0682034
• Device Lot Number: ASDNF033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1