MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	LH-0032YN
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported that, as per dr, when she opened the non coring needle for accessing the port as soon as she attached the syringe the needle started leaking.She never applied any pressure or flushed the needle but the flow came through the non coring needle.When they physically checked the non coring needle at the hospital with the same dr the needle was not leaking, but the dr forcefully told them when she tried at the patient bedside it was leaking and was not ready to accept that their is no leakage in the product.Incident occurred before usage, required a new unit.
Event or Problem Description
It was reported that, as per dr, when she opened the non coring needle for accessing the port as soon as she attached the syringe the needle started leaking.She never applied any pressure or flushed the needle but the flow came through the non coring needle.When they physically checked the non coring needle at the hospital with the same dr the needle was not leaking, but the dr forcefully told them when she tried at the patient bedside it was leaking and was not ready to accept that their is no leakage in the product.Incident occurred before usage, required a new unit.
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 leaking infusion set is unconfirmed because the problem could not be reproduced.One 20 ga x 1.0 in.Safestep infusion set with y-site was returned for evaluation.An initial visual observation showed saline use residues along the inside of the infusion set.A functional test of attempting to pressurize the infusion set with water using a 12 ml syringe in each lumen revealed no observed leaks throughout the infusion set.An attempt to infuse water into the infusion set using a 12 ml syringe revealed the device was patent to infusion.Because the infusion set was not observed to leak during functional testing, the complaint of a leaking infusion set is unconfirmed.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h.11.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 1 IN WITH Y-SITE
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18545440
• Report Number: 3006260740-2024-00134
• Device Sequence Number: 18371481
• Product Code: FPA
• UDI-Device Identifier: 00801741066238
• UDI-Public: (01)00801741066238
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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: 01/04/2026
• Device Catalogue Number: LH-0032YN
• Device Lot Number: ASHNFC024
• 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: 01/03/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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