MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MINILOC SAFETY INFUSION SET 20G X 0.75IN Y-SITE MEDEGEN NEEDLELESS INJECTION CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	S02320-75
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported that when flushing the minilock its leaking from the yellow butterfly connector by the tubing.No other information provided, at this time.It was reported that this has happened 6 times when flushing the miniloc.This report addresses all 6 devices.
Event or Problem Description
It was reported that when flushing the minilock its leaking from the yellow butterfly connector by the tubing.No other information provided, at this time.It was reported that this has happened 6 times when flushing the miniloc.This report addresses all 6 devices.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The complaint of a leak could not be confirmed.The product returned for evaluation was 22 sealed and 2 opened 20g x 0.75in.Miniloc infusion sets w/y-site.A gross visual inspection of the returned units found no damage or defects to the components.All units were leak tested by flushing with water using a luer lock syringe.During testing no leaks were observed.Based on the available evidence, the reported defect could not be confirmed.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 0.75IN Y-SITE MEDEGEN NEEDLELESS INJECTION CAP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city UT 84116
• Manufacturer Contact: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20334305
• Report Number: 3006260740-2024-05603
• Device Sequence Number: 7878409
• Product Code: FPA
• UDI-Device Identifier: 00801741048968
• UDI-Public: (01)00801741048968(11)240119(17)260712(10)ASHUFC061
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 03/10/2025

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: 07/12/2026
• Device Catalogue Number: S02320-75
• Device Lot Number: ASHUFC061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown