MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EZ HUBER 19G X 19MM; 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	04/17/2024
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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by the customer "i wanted to give the patient antibiotics via the venous port.About 3 hours before, it was still possible to give infusions without any problems.Now, however, it was no longer possible to either flush or aspirate blood.Blood had collected at the front of the line (at the y-connection).In the end, the needle had to be pulled out.2 nurses had tried to flush.After the needle was pulled out, i tried to flush it again, it was very difficult at first, but then it worked.There was a risk of an air embolism due to the leak in the tube.However, the patient showed no symptoms of an air embolism and never expressed any complaints." 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 infusion set is unconfirmed because the problem could not be reproduced.One 19 ga x 0.75 in.Ez huber infusion set with y-site was returned for evaluation.An initial visual observation revealed blood use residues throughout the returned infusion set.It was observed that the safety mechanism was advanced over the distal needle tip.A functional test of attempting to infuse water into the proximal luer of the returned infusion set using a 12 ml syringe revealed no leaks throughout the device.The proximal luer was patent to infusion.A functional test of attempting to infuse water into the y-site luer of the returned infusion set using a 12 ml syringe revealed no leaks throughout the device.The y-site luer was patent to infusion.The safety mechanism was carefully removed from the device.Both the proximal luer and the y-site luer were pressurized with water using a 12 ml syringe and no leaks were observed throughout the returned infusion set.A microscopic observation of the returned infusion set revealed nothing remarkable along the device.Because the leak could not be identified, the complaint of a leaking infusion set is unconfirmed.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer "i wanted to give the patient antibiotics via the venous port.About 3 hours before, it was still possible to give infusions without any problems.Now, however, it was no longer possible to either flush or aspirate blood.Blood had collected at the front of the line (at the y-connection).In the end, the needle had to be pulled out.2 nurses had tried to flush.After the needle was pulled out, i tried to flush it again, it was very difficult at first, but then it worked.There was a risk of an air embolism due to the leak in the tube.However, the patient showed no symptoms of an air embolism and never expressed any complaints." no other information was provided.

• Brand Name: EZ HUBER 19G X 19MM
• 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): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19381105
• Report Number: 3006260740-2024-02572
• Device Sequence Number: 14384589
• Product Code: FPA
• UDI-Device Identifier: 00801741089138
• UDI-Public: (01)00801741089138
• 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
• Report Date (Section B): 08/14/2024

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: REGV1238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 08/23/2024
• 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: 80 YR
• Patient Sex: Unknown