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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refs1473 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that cancer patient bought huber plus from pharmacy in this hospital and brought to facility.Staff nurse opened this box of huber plus and inserted needle to chemoport and connected luer lock syringe contained 10ml of normal saline to main hub.She infused with 10ml normal saline and saw saline leaked and spilled from y-site.She stopped the procedure and informed head of nurse and pharmacist.Cancer patient is fine.
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, 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-injection site was confirmed, but the exact cause of the leak could not be determined from the video that was provided for investigation.The video showed a 20g huber plus infusion set during use.During infusion, a clear fluid was leaking from the blue valve on the y-injection site.Both a spraying leak and drops of fluid are shown at the valve.While the cause of the leak could not be determined from the video, potential contributing factors include deformation of the valve housing or damaged valve stem.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.=.
Event or Problem Description
It was reported that cancer patient bought huber plus from pharmacy in this hospital and brought to facility.Staff nurse opened this box of huber plus and inserted needle to chemoport and connected luer lock syringe contained 10ml of normal saline to main hub.She infused with 10ml normal saline and saw saline leaked and spilled from y-site.She stopped the procedure and informed head of nurse and pharmacist.Cancer patient is fine.

• 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: 13078249
• Report Number: 3006260740-2021-05410
• Device Sequence Number: 4152552
• 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): 01/20/2022

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: REFS1473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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: Male