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
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refq1860 showed fifteen other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported leakage from y site connector when performing flushing prior to use.No other information was provided.
Additional 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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking infusion set was confirmed; however, the root cause was not identified.The product returned for evaluation was one 20ga x 1¿ huber plus safety infusion set with valved y-site.Usage residues were observed throughout the sample and the safety mechanism was engaged.The y-site valve orifice appeared elliptical.Microscopic inspection of the y-site confirmed the orifice to be elliptical.Inspection of the y-site orifice using an iso taper gauge revealed the y-site to be outside of manufacturing specifications.The shape of the luer prevented full insertion of the taper gauge.An attempt to infuse water through the sample using a 12m syringe revealed the sample to be patent to infusion; however, a spraying leak was observed emanating from the y-site valve septum.The misshapen valve housing appeared to be the cause of the valve septum leakage.The lack of evidence of attempted use and the lack of mechanical damage suggested the valve housing deformation did not occur during device use; however, it could not be determined if the deformation occurred during the manufacturing process or due to subsequent environmental conditions.Potential contributing factors include exposure to excessive heat during shipping/storage.
Event or Problem Description
It was reported leakage from y site connector when performing flushing prior to use.No other information was provided.

• Brand Name: HUBER PLUS 20G X 1" NEEDLELESS Y SITE
• Common Device Name: 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13419396
• Report Number: 3006260740-2022-00128
• Device Sequence Number: 14670152
• Product Code: FPA
• UDI-Device Identifier: 00801741065569
• UDI-Public: (01)00801741065569
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K993848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2022

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 012001NY
• Device Lot Number: REFQ1860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown