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

Catalog Number	7N8370K
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a one-link non-dehp y-type microbore catheter extension set separated.It was further reported that during an unspecified patient infusion, the one-link came off the "luer stem".The set was changed out.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the provided photograph, the male luer lock was observed separated from the tubing.Due to the nature of the sample, no additional testing could be performed.The reported condition was verified.The cause of the condition could not be determined.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
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12643187
• Report Number: 1416980-2021-06300
• Device Sequence Number: 14583438
• Product Code: FPA
• UDI-Device Identifier: 00085412613505
• UDI-Public: (01)00085412613505
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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: 7N8370K
• Device Lot Number: DR20L18239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED SOLUTION
• Patient Sex: Unknown