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

Catalog Number 7N8301

Device Problems Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Potential lot number ur19c27030 or ur19g31041.(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified quantity of one-link non-dehp standard bore catheter extension sets experience connection issues between distal end and the intravenous (iv) catheter which resulted in a leak.The customer was having issues securing the extension set to the iv connector which resulted in a leak that the connection.This issue was identified during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information : suspect lot ur19c27030 was manufactured on 03/29/2019.Suspect lot ur19g31041 was manufactured on 08/01/2019.A batch review was conducted for suspect lots ur19c27030 and ur19g31041; there were no deviations found related to this reported condition during the manufacture of these lots.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: EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; see h10; see h10; see h10
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9317745
• MDR Text Key: 168003333
• Report Number: 1416980-2019-06321
• 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,distri
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 7N8301
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1