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	06/21/2021
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.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of component damage - no leak 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 30262e because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the 40 inch ext w/2 vlv ports luer was damaged.The following information was provided by the initial reporter: "male luer bent.".
Event or Problem Description
It was reported that the 40 inch ext w/2 vlv ports luer was damaged and leaked.The following information was provided by the initial reporter: "male luer bent".
Additional Manufacturer Narrative
Correction: additional information was provided by the customer.The following fields have been updated: b.3.Date of event: (b)(6) 2021.B.5.Describe event or problem: it was reported that the 40 inch ext w/2 vlv ports luer was damaged and leaked.D.2.Medical device lot#: 20129642.D.4.Medical device expiration date: 2023-12-18.D.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2021-09-08.H.4.Device manufacture date: 2020-12-14.Investigation: h.6.Investigation summary: two samples of lot number 20129642 were received for quality investigation.The customer complaint of component damage - leak could not be verified.The submitted samples were first visually inspected to determine if the customers complaint that the male luer connector tubing was bent.Inspection of the male luer connector did not indicate any bends or misalignment of the male luer tubing.The male luer connection collar was pushed forward and looked as if the tubing was bent however, the collar is able to be pushed back and spins, and therefore can be realigned without any damage to the device.The male luer connector was then connected to a female luer adapter and fluid pushed through the connection to check for leakage.There was no leakage observed.No further issues were observed during this investigation.A device history record review for model 30262e lot number 20129642 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 08dec2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause for this issue could not be determined because the reported failure could was not replicated.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.

• Brand Name: 40 INCH EXT W/2 VLV PORTS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12208036
• Report Number: 9616066-2021-51607
• Device Sequence Number: 4412271
• Product Code: FPA
• UDI-Device Identifier: 37613203011489
• UDI-Public: 37613203011489
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/08/2021

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: 12/18/2023
• Device Model Number: 30262E
• Device Catalogue Number: 30262E
• Device Lot Number: 20129642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 09/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2020
• 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