MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HUBER PLUS 20G X 1" NEEDLELESS Y SITEN; 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	06/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refz3311 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in malaysia.
Event or Problem Description
It was reported that nurse accessed chemoport with huber plus and flushed with normal saline from the main hub.There was leaking from y-connector hub.Nurse de-accessed chemoport and opened a new box of huber plus to continue treatment.
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-site hub is confirmed but the exact cause is unknown.One huber plus 20 ga x 1 in infusion set device was returned without product packaging.An inspection of the device revealed the y-site hub to contain an oval shaped deformation.The proximal hub was flushed with water and a spraying leak emanated from the y-site hub.Microscopic observation of the y-site revealed a gap between the blue valve and white housing due to the deformation.The condition of the tray packaging is unknown; however, exposure to heat appears to have affected the warping of the hub.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.Since the warped hub was found to be the cause of the leak, the complaint is confirmed; however, the exact source of the damage remains unknown.A review of the manufacturing records did not reveal any evidence to suggest a manufacturing-related root cause.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that nurse accessed chemoport with huber plus and flushed with normal saline from the main hub.There was leaking from y-connector hub.Nurse de-accessed chemoport and opened a new box of huber plus to continue treatment.

• Brand Name: HUBER PLUS 20G X 1" NEEDLELESS Y SITEN
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14962248
• Report Number: 3006260740-2022-02624
• Device Sequence Number: 5372364
• 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): 08/17/2022

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: REFZ3311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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: Female