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	Backflow (1064); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that a t-conn w/ll & 1 vlv port experienced blood backflow and ruptured tubing during use.The following was reported by the initial reporter: "i received this product this morning with the attached note.Product is available and lot # is (10) 20126459 mom reported iv tubing was leaking.Rn assessed and found blood backing up in the bd smartsite extension set (ref20041e).Fluid leaking from a hole in the tubing between the thin tubing portion and the "hub" of the catheter.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-05-25.H6: investigation summary one sample was received for quality investigation.The customer complaint of component damage - leak and flow issues - back flow was verified by testing.The sample was primed and a leak was immediately noticed at the connection point between the female luer adapter and the connection tubing.A device history record review for model 20041e lot number 20126459 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10dec2019.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the issues reported in this complaint is a lack of solvent between the tubing and the female luer adapter.The solvent between the female luer adapter and tubing is sufficient to keep the two component connected, however, the solvent did not seal the union between the two components completely and therefore leakage is seen coming from that connection point.The leakage seen from the tubing is also the cause for the backflow reported by the customer.Since the unsealed tubing acts as an open point in the tubing, both fluids from the iv set and from the patient would escape through the opening created.H3 other text : see h10.
Event or Problem Description
It was reported that a t-conn w/ll & 1 vlv port experienced blood backflow and ruptured tubing during use.The following was reported by the initial reporter: "i received this product this morning with the attached note.Product is available and lot # is (10) 20126459 mom reported iv tubing was leaking.Rn assessed and found blood backing up in the bd smartsite extension set (b)(4).Fluid leaking from a hole in the tubing between the thin tubing portion and the "hub" of the catheter.".

• 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
• MDR Report Key: 11963530
• Report Number: 2243072-2021-01642
• Device Sequence Number: 1375126
• Product Code: FPA
• UDI-Device Identifier: 27613203021665
• UDI-Public: 27613203021665
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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 Expiration Date: 12/23/2023
• Device Model Number: 20041E
• Device Catalogue Number: 20041E
• Device Lot Number: 20126459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1