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

Catalog Number 2C8419

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 the vented solution set deflated when the bag was compressed.The bag was not holding its seal.This occurred before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The reported broken seal involved sterile fluid path packaging, not sterile packaging.Therefore, the original reported issue should not have been reported as the fluid path remains sterile regardless of the condition of the packaging.The device was returned for evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A visual inspection of the returned used sample found that the packaging was sealed.The packaging of the device employs breathable material which is why the customer found that it deflated upon compression.Although the packaging allows for air to enter and exit the package, the fluid path of the set remains sterile as the end caps on the set are the components that maintain the sterile barrier.The reported condition was not verified.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 02573 ; SN 02573
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 02573 ; SN 02573
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5346798
• MDR Text Key: 35176688
• Report Number: 1416980-2016-00343
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/18/2020
• Device Catalogue Number: 2C8419
• Device Lot Number: SR15C18017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2015
• 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