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

Catalog Number 2N3328

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Cardiac Arrest (1762)

Event Date 06/22/2022

Event Type  Injury  

Event Description

It was reported while attempting to give a dose of epinephrine during a patient "code", the rubber stopper of an interlink system non-dehp t-connector extension set became dislodged and the patient did not receive the dose of medication.The "dose was repeated and compressions were initiated." the cause of the dislodgement was not reported.At the time of this report, the patient outcome was not reported.No additional information is available.

Manufacturer Narrative

The event occurred on an unspecified date in 2022.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Five (5) samples were received for evaluation.Three (3) of the samples were received used and inside of another biohazard zip lock bag.One of the three samples was not manufactured at baxter aibonito (as per drawing of product).Of the remaining four (4) samples, two unused samples were related to the lot number of this report and had no obvious defects observed.However, in the two used samples, (the septum of the non-retractable male luer lock), was observed above the swage ring and in one of these samples the alert ring was observed with variable width, but the hot stamp ring was continuous.Functional, pressure and clear passage tests were only performed on the two unused samples with issues noted.The reported condition was not verified.These tests were not performed on the other two samples due to the condition of how the samples were received.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B3: add (omitted on initial) d9: device available for evaluation?: remove: ¿yes and the date of (b)(6) 2022¿ (leave as ¿no¿ as in initial report).H2: if follow-up, what type?: remove: ¿device evaluation¿ (leave additional information only).H3: device returned for evaluation? remove: ¿yes¿ (leave blank) h3: manufacturer evaluated device? remove "yes" (leave blank) h3: evaluation summary attached? remove "yes" (leave blank) h6: type of investigation code: remove b01 (leave b17, b14) h6: investigation findings code: remove c13 (leave c20) h10: remove the following sample evaluation results: (evaluation does not apply to this report).Five (5) samples were received for evaluation.Three (3) of the samples were received used and inside of another biohazard zip lock bag.One of the three samples was not manufactured at baxter aibonito (as per drawing of product).Of the remaining four (4) samples, two unused samples were related to the lot number of this report and had no obvious defects observed.However, in the two used samples, (the septum of the non-retractable male luer lock), was observed above the swage ring and in one of these samples the alert ring was observed with variable width, but the hot stamp ring was continuous.Functional, pressure and clear passage tests were only performed on the two unused samples with issues noted.The reported condition was not verified.These tests were not performed on the other two samples due to the condition of how the samples were received.The cause of the condition could not be determined.H10: leave the following results: (as initially reported) a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed 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
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15297947
• MDR Text Key: 298655354
• Report Number: 1416980-2022-04447
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412004662
• UDI-Public: (01)00085412004662
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K921899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2N3328
• Device Lot Number: UR21L19035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EPINEPHRINE
• Patient Outcome(s): Required Intervention