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

Catalog Number	7N8391
Medical Device Problem Codes	Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturer address 1: (b)(4).F2: medwatch report number: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity of one-link non-dehp standard bore catheter extension sets disconnected which resulted in a fluid leak.During injection of intravenous (iv) contrast/saline, the extension tubing loosened, and fluid spilled out.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H4: device manufactured between december 02, 2021 to december 03, 2021.H10: the actual device was not available; however, seven (7) companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All components are correctly placed and according to specifications.Functional testing including pressure test and clear passage test was performed with no issues were noted.Pull testing was also performed and no defects 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
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14118675
• Report Number: 1416980-2022-01838
• Device Sequence Number: 14515375
• Product Code: FPA
• UDI-Device Identifier: 00085412475400
• UDI-Public: (01)00085412475400
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 7N8391
• Device Lot Number: R21K27017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown