MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G X 0.5IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	LH-0035YN
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
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 manufacturer has received the sample and is pending evaluation.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported that the port needle had been insitu for about 3 days when the nurse noticed it started leaking when they were flushing through one side of the y set.The was no increase of resistance during flushing and the port is not blocked.The port needle set has one bonded needleless device and one where we have to attach a single needleless device.It was the bonded needleless device that was leaking.No harm was caused to the patient, the port needle was removed early due to the issue and a different needle inserted.No other information provided, at this time.
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 was confirmed; however, the root cause was not identified.The product returned for evaluation was one segment of digital video which depicted a safestep safety infusion set.The video depicted the valved y-site.During infusion in the video, small beads of red fluid were visible exiting the y-site around the blue valve septum.Leakage was observed in the video; however, inspection of the video was insufficient to identify the cause of the leak.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.
Event or Problem Description
It was reported that the port needle had been insitu for about 3 days when the nurse noticed it started leaking when they were flushing through one side of the y set.The was no increase of resistance during flushing and the port is not blocked.The port needle set has one bonded needleless device and one where we have to attach a single needleless device.It was the bonded needleless device that was leaking.No harm was caused to the patient, the port needle was removed early due to the issue and a different needle inserted.No other information provided, at this time.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.5IN 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 UT 84116
• Manufacturer Contact: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21115053
• Report Number: 3006260740-2024-08248
• Device Sequence Number: 8733278
• Product Code: FPA
• UDI-Device Identifier: 00801741066290
• UDI-Public: (01)00801741066290(11)240623(17)260913(10)ASHWFC023
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 01/27/2025

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: 09/13/2026
• Device Catalogue Number: LH-0035YN
• Device Lot Number: ASHWFC023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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