MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EZ HUBER NW NY 20GA X; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

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.H3 other text : device not returned.

Event Description

It was reported by the customer that due to the child's activity, a strong pull was repeatedly applied to the infusion line.The outer tube tore out and the inner tube remained intact.The infusion volume could be infused normally.Resistance was noticeable when taking blood and it was more difficult.The defect is in the same place as with the last flu needle, but it is not torn apart, but simply a leak.Fluid has escaped from this leak.The tube has 3 spots that look different from the rest of the tube.The port needle is connected to a central system.Bacteria could become trapped and cause an infection with sepsis in the oncological patient.In the worst case, this can lead to death.It was reported this occurred with two devices.This report addresses the second device.

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 break is confirmed and was determined to be use related.The products returned for evaluation were two ez huber infusion sets without a y-site.One of the infusion sets did not exhibit any damage.The other infusion set was returned with a complete break in the extension tube.The needle and safety mechanism were not returned.The sample with a complete break in the extension tube exhibited use residue throughout the device.The tube distal of the luer connector was severely elongated and exhibited multiple bends.Microscopic inspection of the break site revealed sharply defined fatigue striations.The surface of the break was uneven.The striations on the break site were consistent with damage caused by material fatigue due to repetitive mechanical stress.This complaint will be recorded for future trending and monitoring purposes.

Event Description

It was reported by the customer that due to the child's activity, a strong pull was repeatedly applied to the infusion line.The outer tube tore out and the inner tube remained intact.The infusion volume could be infused normally.Resistance was noticeable when taking blood and it was more difficult.The defect is in the same place as with the last flu needle, but it is not torn apart, but simply a leak.Fluid has escaped from this leak.The tube has 3 spots that look different from the rest of the tube.The port needle is connected to a central system.Bacteria could become trapped and cause an infection with sepsis in the oncological patient.In the worst case, this can lead to death.It was reported this occurred with two devices.This report addresses the second device.

• Brand Name: EZ HUBER NW NY 20GA X
• Type of Device: 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: 18580630
• MDR Text Key: 334272690
• Report Number: 3006260740-2024-00192
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SHNWG20-60
• Device Lot Number: REGQ1535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other