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
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a crack in the y-site was confirmed, but the exact cause could not be determined from the photograph that was provided for investigation.The photo showed a y-injection site from an infusion set.A non-vad injection cap was attached to the y-injection site.What appeared to be a longitudinal crack was observed in the y-injection site adjacent to the injection cap.The clamp was closed over the extension set tubing distal to the y-injection site.A red colored fluid was observed inside the extension set and the y-injection site.Since the crack was observed in the photo, the complaint was confirmed; however, the exact cause could not determined.A lot history review (lhr) of asdvf024 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the miniloc leaked at the y-site.No other information was provided.

• 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: 10009113
• Report Number: 3006260740-2020-01547
• Device Sequence Number: 2941489
• Product Code: FPA
• UDI-Device Identifier: 00801741048043
• UDI-Public: (01)00801741048043
• 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): 04/29/2020

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: 0682034
• Device Lot Number: ASDVF024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1