MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. T-CONN W/LL & 1 VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Model Number	20041E
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	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that 8 t-conn w/ll & 1 vlv port experienced flow issues, and were clogged.The following information was provided by the initial reporter: valve malfunction, unable to inject or have resistance.
Event or Problem Description
It was reported that 8 t-conn w/ll & 1 vlv port experienced flow issues, and were clogged.The following information was provided by the initial reporter: valve malfunction, unable to inject or have resistance.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 9/14/2021.H.6.Investigation: eight 20041e samples were received without packaging for investigation.No connecting products were received to assist the investigation.A visual inspection of the returned samples did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience.Functional testing was performed by connecting a retained 50ml bd plastipak syringe from stock to the returned samples; in each instance no flow restrictions or occlusions were identified.The details of this feedback were forwarded to the manufacturing site for investigation.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.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.
Additional Manufacturer Narrative
Correction: supplemental report stated that bd has conducted an in-depth investigation, capa#1998036, to identify any potential contributing factors for occlusion of this nature.This complaint was not part of capa #1998036 h3 other text : see h10.
Event or Problem Description
It was reported that 8 t-conn w/ll & 1 vlv port experienced flow issues, and were clogged.The following information was provided by the initial reporter: valve malfunction, unable to inject or have resistance.

• Brand Name: T-CONN W/LL & 1 VLV PORT
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12512181
• Report Number: 9616066-2021-52108
• Device Sequence Number: 924497
• Product Code: FPA
• UDI-Device Identifier: 27613203021665
• UDI-Public: 27613203021665
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2021

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: 20041E
• Device Catalogue Number: 20041E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/29/2021; 12/22/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/22/2021; 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown