MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HUBER PLUS 20G X1" 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	03/08/2022
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 refr4080 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (refr4080) have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported that cancer patient bought huber plus from pharmacy and brought to the oncology unit.Staff nurse opened the huber plus and prime the needle from main hub but did not prime from y-site.She 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 immediately.Oncology staff nurse opened a new huber plus needle that bought by patient and it had the same leakage problem.Oncology staff nurse opened another huber plus needle bought by patient to continue procedure.Cancer patient is fine.This report addresses the second needle used.

• Brand Name: HUBER PLUS 20G X1" 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13967588
• Report Number: 3006260740-2022-01039
• Device Sequence Number: 5053271
• 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
• Report Date (Section B): 03/30/2022

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: REFR4080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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 Age: 72 YR
• Patient Sex: Female