MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 19G X 0.5IN; 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	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported extension breaks during usage causing leaking of chemotherapy and biological fluids.Occurred during use.Nurses have found several port needle extensions broken during infusion in pediatric patients of around 4-5 years old.This causes leakage of chemotherapy and biological fluids.It has been necessary to remove the needle and prick the reservoir with a new one to continue with the treatment.Exposure to blood and cytotoxics.It was reported this occurred with 5 devices.This report addresses the fourth device.
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.

• Brand Name: SAFESTEP HUBER NEEDLE SET 19G X 0.5IN
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20008071
• Report Number: 3006260740-2024-04562
• Device Sequence Number: 14546526
• Product Code: FPA
• UDI-Device Identifier: 00801741066368
• UDI-Public: (01)00801741066368
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K153440
• 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
• Report Date (Section B): 08/15/2024

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 Model Number: N/A
• Device Catalogue Number: LH-0039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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