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

Catalog Number	7N8377
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the luer lock at the bottom of the y of a one-link non-dehp y-type standard bore catheter extension set was "seized".This issue was identified during setup.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d10, h3, h4 and h6.H10: the device was received for evaluation.Visual inspection was performed using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.A functional testing was performed including pressure test and clear passage test with satisfactory results; however, the luer lock was stuck on its male adapter.The reported condition was verified.The cause of the condition was due to manufacturing process.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 LV CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10228330
• Report Number: 1416980-2020-03722
• Device Sequence Number: 10891410
• Product Code: FPA
• UDI-Device Identifier: 00085412091808
• UDI-Public: (01)00085412091808
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K132734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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: 7N8377
• Device Lot Number: DR20A14039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 8040700¿12/04/19¿001-C
• Patient Sequence Number: 1