MAUDE Adverse Event Report: EXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	7N8310
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred during the unspecified date and month of year 2021.Initial reporter facility name: southern tennessee regional health system imaging dept.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the unspecified quantity of one-link non-dehp microbore catheter extension sets had disconnection issues with contrast leaking.The disconnection was coming from the part where it screwed into the intravenous catheter.The contrast would leak out mid injection, as a result the patient¿s did not receive enough contrast and the ct results would be undiagnostic; or the patient would have to receive extra radiation to compensate for the lack of enough contrast.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The actual device was not available; however, a companion sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional test was performed which included securing the in-line connection, priming the set, purging the air, opening and closing the slide clamp with no issues were noted.Additionally, functional clear passage and pressure tests were performed; and no issues were observed.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12416550
• Report Number: 1416980-2021-05419
• Device Sequence Number: 3576638
• Product Code: FPA
• UDI-Device Identifier: 00085412476728
• UDI-Public: (01)00085412476728
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K132734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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 Catalogue Number: 7N8310
• Device Lot Number: UR21C19025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 10/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONTRAST; CONTRAST