MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK SYSTEM T-CONNECTOR EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2N3328

Device Problems Break (1069); Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a connection issue with an unspecified quantity of interlink system non-dehp t-connector extension sets; further stated as the t connectors could not connect with a non-baxter catheter.It was further reported that the threaded component of an unspecified quantity of extension sets were not completely round and would slip into the non-baxter catheter.These issues occurred prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

B3/d10: the events occurred over the past few months.B5: it was further reported at least five (5) sets were damaged.H10: one (1) actual device was received for evaluation.Visual inspection was performed which observed that the non-retractable male luer lock was damaged in the luer stem; this could result in difficulty connecting the device.The reported condition was verified on the returned sample.The cause of the condition was due to the machine during the manufacturing process.A nonconformance has been opened to address this issue.The remaining devices were not returned; therefore a device analysis could not be completed for those samples.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: INTERLINK SYSTEM T-CONNECTOR EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11685979
• MDR Text Key: 246270792
• Report Number: 1416980-2021-02207
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412004662
• UDI-Public: (01)00085412004662
• Combination Product (y/n): Y
• PMA/PMN Number: K921899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 2N3328
• Device Lot Number: UR20H23035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 05/19/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BD INSIGHT AUTOGUARD CATHETER (NON-BAXTER)