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

Catalog Number	7N8371
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tubing of a one-link non-dehp y-type microbore catheter extension set came apart from the luer lock on the y site.It was further reported that the intravenous (iv) line "snapped"; further described as the white lumen y site broke and resulted in blood coming out of the patient's line.The line was clamped, cleaned, and the clave and iv products were changed.It was not specified when in the process step this occurred.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h3 and h6.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed on the photograph which observed that the male luer lock came apart (separated) form the tubing.The reported condition was verified.The cause of the condition could not be determined.Due to the nature of the sample, no additional testing could be performed.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: 12096026
• Report Number: 1416980-2021-03998
• Device Sequence Number: 4013847
• Product Code: FPA
• UDI-Device Identifier: 00085412091822
• UDI-Public: (01)00085412091822
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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 Catalogue Number: 7N8371
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 08/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ANALGESIA; HEPARIN; TOTAL PARENTERAL NUTRITION (TPN); ANALGESIA; HEPARIN; TOTAL PARENTERAL NUTRITION (TPN)