MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EZ HUBER 20GX1IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	SHW20-100YS
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
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 reeu2830 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported while trailing huber needles, the clinicians had a few leaks at the y-site hub as they are flushing at the end connection.The blue center of the hub pops out a little and it leaks.The facility said they are unsure if it is due to pressure or another factor but stated their concern for patient and staff safety if it were to happen with chemo instead of just saline.
Event or Problem Description
It was reported while trialing huber needles, the clinicians had a few leaks at the y-site hub as they are flushing at the end connection.The blue center of the hub pops out a little and it leaks.The facility said they are unsure if it is due to pressure or another factor but stated their concern for patient and staff safety if it were to happen with chemo instead of just saline.
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 valved y-site was inconclusive due to the nature of the returned sample.The product returned for evaluation was one photograph depicting a 20ga x 1¿ ez huber safety infusion set.The safety mechanism was engaged.An arrow was drawn on the photograph pointing to the proximal luer adapter.A circle was drawn around the valved y-site.No leakage from the y-site was evident in the submitted photograph; however, the sample could not be thoroughly examined or functionally evaluated.Consequently this complaint is inconclusive at this time.H3 other text : evaluation findings are in section h.11.

• Brand Name: EZ HUBER 20GX1IN WITH 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
• MDR Report Key: 10880573
• Report Number: 3006260740-2020-20629
• Device Sequence Number: 2758301
• Product Code: FPA
• UDI-Device Identifier: 00801741089800
• UDI-Public: (01)00801741089800
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K040533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: SHW20-100YS
• Device Catalogue Number: SHW20-100YS
• Device Lot Number: REEU2830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2020
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other