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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/25/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refq2454 showed three other similar product complaint(s) from this lot number.

Event Description

It was reported that leakage from y site needleless connection during flushing on 3 piccs.It was stated the devices weren't used on a patient.They found the leakage when they were performing the pre-flush prior to inserting the needle into the chemoport.Saline was used for flushing.This report addresses the first 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 in the y-site was confirmed; however, the exact mechanism could not be determined.Three huber plus infusion sets were returned for investigation.A microscopic examination of the y-site revealed that the valve housing was out of round.A luer taper gage could not be inserted into the y-site due to the deformation of the valve housing.A functional test revealed fluid leaking from the y-site valves due to the deformation in the valve housing.A review of the manufacturing records showed that the lot met all release criteria.The huber plus infusion sets are 100% leak tested during the manufacturing process.It appears that the y-site valve housing was deformed after the manufacturing process and testing.It is possible that the deformation was caused if the product was exposed to excessive heat outside bd control; however, it could not be determined where or how the product was damaged.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that leakage from y site needleless connection during flushing on 3 needles.It was stated the devices weren't used on a patient.They found the leakage when they were performing the pre-flush prior to inserting the needle into the chemoport.Saline was used for flushing.This report addresses the first device.

• Brand Name: HUBER PLUS 20GX 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12629139
• MDR Text Key: 276380713
• Report Number: 3006260740-2021-04365
• 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: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• 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: REFQ2454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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