MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HUBER PLUS 20G X 1" NEEDLELESS Y SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refs1473 showed three other similar product complaint(s) from this lot number.

Event Description

It was reported that three needles exhibited leakage from y site connector.No other information was provided.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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a leak at the y-site hub is confirmed but the exact cause is unknown.Two huber plus 20 ga x 1 in infusion set devices were returned in open packaging.Both trays exhibited deformation which appeared to be caused by heat damage.The flanges were curled and warped.The tyvek lid was returned peeled; however, evidence of a complete seal was observed.An inspection of the infusion sets showed the y-site hubs to contain an oval shaped deformation.The infusion sets were flushed with water and leaks were noted at the y-site hubs.Microscopic observation of the y-site revealed a gap between the blue valve and white housing due to the deformation.The exposure to heat appears to have affected the warping of the tray packaging and infusion sets.This type of damage can occur from prolonged exposure to excessive heat, and the damage was most likely associated with shipping or environmental conditions outside bd control.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that three needles exhibited leakage from y site connector.No other information was provided.This report addresses the second device.

• Brand Name: HUBER PLUS 20G X 1" NEEDLELESS Y SITE
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13061270
• MDR Text Key: 282629204
• Report Number: 3006260740-2021-05402
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741065569
• UDI-Public: (01)00801741065569
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K993848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• 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: 012001NY
• Device Lot Number: REFS1473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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