MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE ACCESS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C7462

Device Problems Break (1069); Split (2537); Chemical Spillage (2894)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that a clearlink secondary medication set had a ¿small hole or split¿ in the tubing, causing medication to spill on the floor.This occurred during infusion.The reporter stated that the hole was near the luer lock end.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).A request for the return of the device has been made.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was returned for evaluation.Visual inspection was performed with no obvious defects noted.A functional test was then performed in which the device was spiked into an in-house, 1000 ml solution bag containing distilled water, reprimed, and observed for leakage.A leak was identified from the tubing just above the male luer.Microscopic examination of the leak site found a cut in the tubing approximately 0.5 inches above the male luer.The cause of the leak was determined to be the cut due to a machine error during the manufacturing process.In order to further investigate and address this condition, a capa was opened.A review of all batch record documents was performed with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition were noted.Should additional relevant information become available, a follow up report will be submitted.

• Brand Name: ACCESS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3812446
• MDR Text Key: 4398972
• Report Number: 1416980-2014-15587
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/09/2019
• Device Catalogue Number: 2C7462
• Device Lot Number: SR14A09029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1