MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP; PORT ACCESS NEEDLE

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	07/31/2025
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 be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported, patient came to treatment area with a chemotherapy bottle hooked up to the port.Patient noticed a bubble in the night in the area of the port that has the needleless injection y site.Patient looked at the port again the next morning and the bubble was bigger.The port is a closed system so patient was very concerned as to why there was a bubble growing in the chamber.Patient arrived to systemic therapy and demanded to get the bottle disconnected even though it was still >60% full.Rn carefully aspirated from the needleless injection y site to remove the bubble and blood return was noted.Port was disconnected.Impact of incident: delay to treatment/therapy.Patient did not get to finish his full dose of chemotherapy.
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 expanding air bubbles within a y-site is inconclusive.Two 19 ga x 0.75 in.Safestep infusion sets were returned for evaluation.An initial visual observation revealed use residue on sample 1 and no evidence of use on sample 2.A functional test of flushing sample 1 with a 12 ml syringe of water was performed, and an air bubble was observed within the y-site; however, no leakage was found.The distal pinch clamp of the infusion set was then engaged, and the sample was pressurized with the 12 ml syringe of water from the proximal luer hub.A droplet of water was observed to form near the valve of the y-site when the sample was pressurized; however, no continuous dripping or leaks were observed.Following this, aspiration was performed with water through the proximal luer hub.An air bubble was observed to remain within the y-site valve after aspiration, and subsequent flushing did not displace the bubble.Sample 2 was flushed with a 12 ml syringe of water, and a smaller air bubble was observed within the y-site; however, no leakage was found.The distal pinch clamp of the infusion set was then engaged, and the sample was pressurized with the 12 ml syringe of water from the proximal luer hub.A droplet of water was observed to form near the valve of the y-site when the sample was pressurized; however, no continuous dripping or leaks were observed.Following this, aspiration was performed with water through the proximal luer hub.The air bubble was observed to disappear and only a very small air bubble remained.The sample was then flushed via the proximal luer hub, and the air bubble was still observed within the y-site valve.No change in the location or increase in size of the bubbles were observed despite attempts to recreate the reported issue.No leaks were found in either sample, and no air was observed to aspirate through the valves of either sample.Therefore, the reported issue of expanding air bubbles could not be confirmed; however, the exact clinical conditions in which the samples were used could be replicated.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: SAFESTEP
• Common Device Name: PORT ACCESS NEEDLE
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22884946
• Report Number: 3006260740-2025-06195
• Device Sequence Number: 8790365
• Product Code: FPA
• UDI-Device Identifier: 00801741066252
• UDI-Public: (01)00801741066252(11)250521(17)271022(10)ASJXFC109
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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 Model Number: N/A
• Device Catalogue Number: LH-0033YN
• Device Lot Number: ASJXFC109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• 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