MAUDE Adverse Event Report: 40 INCH EXT W/2 VLV PORTS; INTRAVASCULAR ADMINISTRATION SET

Model Number	30262E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 when using the 40 inch ext w/2 vlv ports there was component separation.The following information was provided by the initial reporter.The customer stated: "the connection came off extension set.There was no clamp slide on the alaris set.".
Additional Manufacturer Narrative
H6: investigation summary: the customer reported that the connector separated from the set and returned one used sample of material #30262e.The sample did not have a piece come off, but was actually misassembled.The set contains a female luer, tubing into one samrt site, tubing into a second smart site, and then tubing into the male luer.This sample matches that description up until the male luer.Instead of a male luer, there is a third smart site attached that is facing the wrong direction.Manufacturing conducted an investigation and found the root cause to be that the operators didn't use two of the fixtures correctly during the assembly process.A quality alert will be generated and the personnel will be refreshed on the assembly process.A device history record review for model 30262e lot number 21029606 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 11feb2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h10.
Event or Problem Description
It was reported when using the 40 inch ext w/2 vlv ports there was component separation.The following information was provided by the initial reporter.The customer stated: "the connection came off extension set.There was no clamp slide on the alaris set.".

• Brand Name: 40 INCH EXT W/2 VLV PORTS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12470768
• Report Number: 9616066-2021-52039
• Device Sequence Number: 12202558
• Product Code: FPA
• UDI-Device Identifier: 37613203011489
• UDI-Public: 37613203011489
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 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 Expiration Date: 02/10/2024
• Device Model Number: 30262E
• Device Catalogue Number: 30262E
• Device Lot Number: 21029606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2021
• 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