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

Catalog Number	LH-0029
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	03/08/2026
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 it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported that the patient contacted the treatment area stating they felt wetness on their nightgown, and the tegaderm dressing was damp.The patient was concerned that chemotherapy may have been leaking from the line.She was instructed to come in for assessment and was advised to remove the nightgown and place it in a biohazard bag, which she did.Upon arrival, the patient¿s port and the ongoing fluorouracil infusion were assessed.The tegaderm dressing was wet to the touch, and a small amount of liquid was visible under the dressing.The port flushed easily with good blood return.The cap attachment at the port was inspected, and the connection was found to be not completely tightened.Staff tightened the cap and all related attachments, removed the wet tegaderm, cleansed the skin, and applied a new tegaderm dressing.The position of the white sensor was adjusted from between the breasts to the side of one breast.Staff noted the possibility that movement of breast tissue may have loosened the cap, though this was not confirmed.The port needle remained in place.The patient left and was instructed to return later the same day once the infusion bottle was empty.When the patient returned, chemotherapy leakage under the tegaderm was again observed, despite the cap having been tightened.Leakage persisted even with the cap secure.There was no serious harm reported.
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 19 ga x 0.75 in.Safestep infusion set with a y-site was returned for evaluation.Functional testing of each luer of the device by pressurizing the infusion set with water revealed the infusion set did not leak during functional testing.Nothing remarkable was observed during a microscopic observation of the infusion set.The complaint of a leaking infusion set is unconfirmed because the problem could not be reproduced.Possible observation of leakage may include poor connection of the infusion set to other devices or other unknown clinical conditions.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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24749953
• Report Number: 3006260740-2026-02149
• Device Sequence Number: 9091917
• Product Code: FPA
• UDI-Device Identifier: 00801741066160
• UDI-Public: (01)00801741066160(11)250924(17)280616(10)ASKTFC058
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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 Catalogue Number: LH-0029
• Device Lot Number: ASKTFC058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• 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