MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EZ HUBER 19G X 19MM WITH Y-SITE; SHG19-75Y

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
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 will evaluate.Results are expected soon.
Event or Problem Description
It was reported, "in the morning, the tube was filled with air.Rinsing with nacl 0.9% and aspiration of blood was not possible.During rinsing, rinsing fluid leaked from the y-piece.As we did not notice the defect immediately, we tried to flush again at the small access of the y-piece.The flushing fluid escaped in a jet from the side of the hose.We stopped immediately and closed the clamp near the port needle." 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.
Event or Problem Description
It was reported, "in the morning, the tube was filled with air.Rinsing with nacl 0.9% and aspiration of blood was not possible.During rinsing, rinsing fluid leaked from the y-piece.As we did not notice the defect immediately, we tried to flush again at the small access of the y-piece.The flushing fluid escaped in a jet from the side of the hose.We stopped immediately and closed the clamp near the port needle." no other information was provided.
Event or Problem Description
It was reported, "in the morning, the tube was filled with air.Rinsing with nacl 0.9% and aspiration of blood was not possible.During rinsing, rinsing fluid leaked from the y-piece.As we did not notice the defect immediately, we tried to flush again at the small access of the y-piece.The flushing fluid escaped in a jet from the side of the hose.We stopped immediately and closed the clamp near the port needle." 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 is confirmed, but the exact cause could not be determined.One photograph of an infusion set y-site was returned for evaluation.An initial visual observation of the photograph showed someone holding the y-site of a device.The y-site was observed to have a longitudinal crack along the luer.Use residues could be seen along the device in the returned photograph.While a crack was observed in the y-site luer in the returned photograph, no details of the split could be discerned.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: EZ HUBER 19G X 19MM WITH Y-SITE
• Common Device Name: SHG19-75Y
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19240400
• Report Number: 3006260740-2024-02125
• Device Sequence Number: 12507829
• Product Code: FPA
• UDI-Device Identifier: 00801741089145
• UDI-Public: (01)00801741089145
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K071846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2025

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: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: SHG19-75
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 06/12/2024; 02/10/2025
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 06/21/2024; 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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 Age: 78 YR
• Patient Sex: Male