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

Catalog Number ACT5435

Device Problems Fluid/Blood Leak (1250); Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The lot numbers found were sr15g08027 and sr15j26032.The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an end user observed cuts causing a leak in the tubing of a solution set.The end user reported that the leak was observed from a cut in the tubing where the tubing feeds into the pump.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Complaint no: (b)(4).The reported lot number sr15g08027 was manufactured on 08-jul-2015 while lot number sr15j26032 was manufactured on 26-oct-2015.Batch reviews were conducted and there were no deviations found related to this reported condition during the manufacture of the potential lots.Visual inspection revealed that the sample has a horizontal/pinch cut across the tubing between 17 and 23 inches below the drip chamber, horizontal to the tubing.Functional testing was performed and revealed that the sample leaked from the tubing in the identified location.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5436797
• MDR Text Key: 38216754
• Report Number: 1416980-2016-03344
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ACT5435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR