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

Model Number	10794983
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: only the patient's age was provided, therefore a default date of birth has been listed.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 that 2 y microbore ext w/luer & 2 sld clp experienced leakage.The following information was provided by the initial reporter: (iv) bifuser leaking in patient's bed twice.Changed iv bifuser first time when the bed and iv tubing were found wet, found it to be leaking again about a half hour later.No visible cracking noted.Infant was not receiving ordered fentanyl drip and versed drip because they were leaking into bed.Infant was extremely agitated and thrashing head around.Infant is intubated and was dangerously agitated.
Additional Manufacturer Narrative
H6: investigation summary : no photo or sample was returned for investigation by our quality team.Without further information or a physical sample, the customer's complaint of leakage cannot be verified and the root cause remains unknown.A device history record review for model 10794983 lot number 20105151 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 15oct2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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 2 y microbore ext w/luer & 2 sld clp experienced leakage.The following information was provided by the initial reporter: (iv) bifuser leaking in patient's bed twice.Changed iv bifuser first time when the bed and iv tubing were found wet, found it to be leaking again about a half hour later.No visible cracking noted.Infant was not receiving ordered fentanyl drip and versed drip because they were leaking into bed.Infant was extremely agitated and thrashing head around.Infant is intubated and was dangerously agitated.

• Brand Name: Y MICROBORE EXT W/LUER & 2 SLD CLP
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12162677
• Report Number: 9616066-2021-51505
• Device Sequence Number: 3713719
• Product Code: FPA
• UDI-Device Identifier: 50885403234291
• UDI-Public: 50885403234291
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 08/10/2021

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: 10/15/2023
• Device Model Number: 10794983
• Device Catalogue Number: 10794983
• Device Lot Number: 20105151
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• 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
• Patient Age: 1 MO