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

Model Number	20019E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported 80 y ext w/vlv ports & 2 sld clp had leakage issues.The following information was provided by the initial reporter: "connector site should be round and connect to syringes.These batches are of an oval shape and therefore won't connect and also leak fluid.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.4.Medical device lot #: 20097046, d.4.Medical device expiration date: 9/29/2023, h.4.Device manufacture date: 9/20/2020.D.4.Medical device lot #: 20115009, d.4.Medical device expiration date: 11/23/2023, h.4.Device manufacture date: 11/23/2020.H.6.Investigation: one hundred and thirty-three 20019e7d samples were received in sealed packaging for investigation; one hundred and thirty were from lot 20097046 and three from lot 20115009.A visual inspection of the returned samples confirmed the customer's experience as the smartsite component of one hundred and seventeen of the returned samples from lot 20097046 were oval shaped.The remaining samples were not identified to have any deformities, furthermore pressure testing did not identify any leakage from the remaining 16 samples.A review of the production records for lot 20097046 and 20115009 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Please note, the root cause of the oval shape is exposure of the smartsite to an external heat source that brings the component temperature above 60°c.The piston head of the smartsite is oval shaped therefore when the round fla component is placed over it, the piston opening is squeezed shut in order to create a seal.Under excessive heat conditions, the fla material can soften, and as the piston pushes back on the inside, it can reshape the fla to conform to the original oval shape of the piston head.Previous investigations have not found a potential root cause for this level of excess heat as a result of any stage of the manufacturing or sterilization processes at the manufacturing site.H3 other text : see h.10.
Event or Problem Description
It was reported 80 y ext w/vlv ports & 2 sld clp had leakage issues.The following information was provided by the initial reporter: "connector site should be round and connect to syringes.These batches are of an oval shape and therefore won't connect and also leak fluid.".

• Brand Name: Y EXT W/VLV PORTS & 2 SLD CLP
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12512062
• Report Number: 9616066-2021-52107
• Device Sequence Number: 924496
• Product Code: FPA
• UDI-Device Identifier: 27613203013813
• UDI-Public: 27613203013813
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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 Expiration Date: 09/29/2023
• Device Model Number: 20019E
• Device Catalogue Number: 20019E7D
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2020
• 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