MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G X 0.75 IN WITH Y-SITE; 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	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that during infusion via female luer connector, the leak was found on y site.Occurred before use, no other information was provided.
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 y-site of an infusion set is confirmed and was determined to be supplier related.One 22 ga x 0.75 in.Safestep infusion set with a y-site was returned for evaluation.An initial visual observation of the returned safestep revealed little use residues throughout the returned device.A functional test of attempting to infuse water into the proximal valve using a 12 ml syringe revealed a leak in the y-site of the infusion set.The leak was observed to be coming out of the blue plug section of the y-site valve.A microscopic observation of the returned infusion set showed water leaking out of the blue valve of the y-site.No additional damage could be seen along the y-site.The complaint of a leaking y-site is confirmed and was determined to be related to the manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that during infusion via female luer connector, the leak was found on y site.Occurred before use, no other information was provided.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.75 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 UT 84116
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20263326
• Report Number: 3006260740-2024-05321
• Device Sequence Number: 8722795
• Product Code: FPA
• UDI-Device Identifier: 00801741066177
• UDI-Public: (01)00801741066177(11)230106(17)250923(10)ASGWFC103
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 01/09/2025

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: 09/23/2025
• Device Model Number: N/A
• Device Catalogue Number: LH-0029YN
• Device Lot Number: ASGWFC103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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