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)
Date of Event	04/03/2020
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, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak at the y-site is confirmed but the exact cause could not be determined from the photo sample provided.Two photo samples of a miniloc infusion set were provided for evaluation.One of the photos showed the product labeling for a 20 ga x 1 in miniloc infusion set with y-site.The product lot showed lot: asdvf012.The second photo shows the ysite section of the device.The clear clamp is engaged over the extension tubing.An infusion device is attached to the main hub connection of the y site.A longitudinal crack appears to be present extending from the proximal end of the hub towards the downward direction.Fluid appears to be within the extension tubing and luer hub.Based on the condition of the sample shown in the photo provided, possible contributing factors include mechanical damage during handling or storage and over-tightening.Since a crack appeared to present, the complaint is confirmed; however, the exact cause could not be determined from the details provided.A lot history review (lhr) of asdvf012 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (asdvf012) have been reported from the same facility.
Event or Problem Description
It was reported that the miniloc was noted to be leaking at the y-site.

• 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: 10005794
• Report Number: 3006260740-2020-01523
• Device Sequence Number: 2740792
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/28/2020

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: ASDVF012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1