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

Catalog Number 7N8377

Device Problem Failure to Disconnect (2541)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported 2 one-link non-dehp y-type standard bore catheter extension sets were unable to disconnect.The issue was further described as "the product does not come apart" and it appears the "one-link is seized to the y-connector".This issue was identified during setup.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the actual device was not available; however, a video of the sample was provided for evaluation.Visual inspection was performed to the video using the naked eye which observed the difficulty of remove the luer activated device from the winged female.The reported condition was verified.The cause of the condition could no be determined.Due to the nature of the returned sample, no additional testing could be performed.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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10088017
• MDR Text Key: 192042001
• Report Number: 1416980-2020-02902
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412091808
• UDI-Public: (01)00085412091808
• Combination Product (y/n): N
• PMA/PMN Number: K132734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 7N8377
• Device Lot Number: DR19L11044
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 8040700¿12/04/19¿001-C
• Patient Sequence Number: 1