MAUDE Adverse Event Report: Y EXT W/VLV PORTS & 2 SLD CLP; INTRAVASCULAR ADMINISTRATION SET

Model Number	20019E
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported y ext w/vlv ports & 2 sld clp had blockage issues.The following information was provided by the initial reporter: "we are having problems with the smartsite extension set ref 20019e.We have had quite a few that will not flush/prime.".
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.It was reported that the smartsite won't flush or prime.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 20019e because a lot number was not provided by the customer.A definitive root cause for the customer's experience could not be determined as no needle-free connector (smartsite) was returned.Following a small number of similar reports, bd has conducted an in-depth investigation, capa#1998036, to identify any potential contributing factors for occlusion of this nature.H3 other text : see h.10.
Event or Problem Description
It was reported y ext w/vlv ports & 2 sld clp had blockage issues.The following information was provided by the initial reporter: "we are having problems with the smartsite extension set ref (b)(4).We have had quite a few that will not flush/prime.".

• Brand Name: Y EXT W/VLV PORTS & 2 SLD CLP
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12389651
• Report Number: 9616066-2021-51926
• Device Sequence Number: 14627532
• Product Code: FPA
• UDI-Device Identifier: 27613203013813
• UDI-Public: 27613203013813
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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: Other
• Device Model Number: 20019E
• Device Catalogue Number: 20019E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 10/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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