MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EZ HUBER 22G X 1.5IN WITH NEEDLELESS Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reep3322 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported via medwatch: "patient accessed with bard portacath needle 22g 3/4-inch needle and when drawing blood air entered the line.All connections were tight but continued to draw air.Needle was removed and a new one was place and no problem." what problem did the user have: "device malfunction - that is, the device did not do what it was intended to do.".

• Brand Name: EZ HUBER 22G X 1.5IN WITH NEEDLELESS 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: 10617527
• MDR Text Key: 209960470
• Report Number: 3006260740-2020-03423
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741089060
• UDI-Public: (01)00801741089060
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2020

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 Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: SH22-75YS
• Device Lot Number: REEP3322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2020
• 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