MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EZ HUBER 22G X 25MM WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed but the exact cause is unknown.Two ez huber infusion sets were returned.One with safety mechanism activated, evidence of use within the tubing, and two infusion caps attached to both luers.The second sample was returned with proximal white luer cap, needle cover over needle, and infusion cap at y site.The first sample was flushed with water using a 12 ml syringe and a spraying leak was observed at the y site.Microscopic observation of the leak location revealed a longitudinal crack in the hub.Microscopic observation of the inner surface revealed material whitening along the crack edges.This is indicative of an internal outward radiating force being applied to the hub.An attempt to remove the infusion valve cap revealed resistance likely caused by over-tightening or dimensional issues between the connections.An iso compliant luer taper gauge was used and the luer was found to be within specification.The second sample was flushed and a stream of water was observed to flow out of the non-bd infusion valve cap attached to the y site.The infusion cap was removed and the infusion set was flushed and pressurized.No leaks were observed.Microscopic observation of the leaking valve cap revealed an clean split near the center of the grey valve.Based on the condition of the returned samples, possible contributing factors include over-tightening and dimensional problems.A lot history review (lhr) of rebs0476 showed two other similar product complaint(s) from this lot number.

Event Description

¿the patient put chemo in a bag as it was leaking from y-site.Four hours later the patient called a nurse and explained it had leaking everywhere.The patient didn't get full dose of chemotherapy.¿ this report addresses the second sample returned.

• Brand Name: EZ HUBER 22G X 25MM WITH Y-SITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 8740864
• MDR Text Key: 149551414
• Report Number: 3006260740-2019-01785
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741089275
• UDI-Public: (01)00801741089275
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071846
• 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
• Report Date: 06/27/2019

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: SHG22-100Y
• Device Lot Number: REBS0476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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