MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ONE-LINK NEUTRAL LUER ACTIVATED DEVICE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 7N8399

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Incomplete or Inadequate Connection (4037)

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

Event Type  malfunction  

Manufacturer Narrative

The devices were not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified quantity of one-link needle-free iv connectors had separation issues from intravenous (iv) catheters resulting in leakage.This was identified during unspecified process steps during computed tomography (ct) with power injectors.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(remove b5 stating): it was reported that an unspecified quantity of one-link needle-free iv connectors had separation issues from intravenous (iv) catheters resulting in leakage.This was identified during unspecified process steps during computed tomography (ct) with power injectors.There was no report of patient injury or medical intervention associated with this event.No additional information is available.(replace b5 with): it was reported that an unspecified quantity of one-link needle-free iv connectors had ¿a poor connection¿ with syringes used in the nuclear medicine department.This was further described as ¿the threads on the one-link do not match up with a firm connection¿.This ¿causes the technologist to double and triple check the connection, sometimes having to hold both the one-link and the syringe while injecting with the other hand because the connection is not stable¿.This was identified in the imaging department with syringes containing a small amount of radioactive isotope.There was no report of patient injury or medical intervention associated with this event.No additional information is available.D10: remove: (iv catheters and power injectors), replace with syringes and radioactive isotope fluid h6: medical device problem codes: (remove a1203 and a050501) replace with a1205 and a1207 h6: component codes: add g04034 (previously blank).H10: should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ONE-LINK NEUTRAL LUER ACTIVATED DEVICE
• 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: 12913602
• MDR Text Key: 281589488
• Report Number: 1416980-2021-07078
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132734
• 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
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7N8399
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2021
• 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: IV CATHETERS; POWER INJECTORS; RADIOACTIVE ISOTOPE FLUID; SYRINGES, CARDINAL