MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MINILOC SAFETY INFUSION SET 19G X 1¿ W/Y-SITE (MEDEGEN NEEDLELESS INJECTION CAP); SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported by the customer that the nurse has inserted miniloc into port and was checking port patency.While aspirating, blood leaked from needleless connector.Nurse stopped the procedure and replaced with a new miniloc.No other information provided.
Event or Problem Description
It was reported by the customer that the nurse has inserted miniloc into port and was checking port patency.While aspirating, blood leaked from needleless connector.Nurse stopped the procedure and replaced with a new miniloc.No other information provided.
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.Based on a review of this information, the following was concluded: the complaint of a drop of blood on the needless connector was confirmed; however, the root cause of that event could not be determined through analysis of the provided video.A video file was provided which showed a miniloc infusion set, which contained a y-site.A syringe was attached to the luer hub of the side-tail extension tubing and flushing of the syringe resulted in a small bead of fluid which developed on the blue valve.No other observations could be made from analysis of the video file.This complaint will be recorded for future trending and monitoring purposes.H3 other text: evaluation findings are in section h11.

• Brand Name: MINILOC SAFETY INFUSION SET 19G X 1¿ W/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 84116
• Manufacturer Contact: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18103617
• Report Number: 3006260740-2023-05086
• Device Sequence Number: 5697904
• Product Code: FPA
• UDI-Device Identifier: 00801741048890
• UDI-Public: (01)00801741048890
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

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: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: S02319-10
• Device Lot Number: ASHPFC009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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