MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HUBER PLUS 20G X 0.75" NEEDLELESS Y SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 04/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reds1094 showed 68 other similar product complaint(s) from this lot number.

Event Description

It was reported that the plastic packaging is deformed and peels off, which leads to the loss of sterility of certain needles.It was stated this occurred with 29 needles.This report addresses the 26th needle.

• Brand Name: HUBER PLUS 20G X 0.75" 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: 10015390
• MDR Text Key: 192075659
• Report Number: 3006260740-2020-01620
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741065637
• UDI-Public: (01)00801741065637
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K993848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 012034NY
• Device Lot Number: REDS1094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 04/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• 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