MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC INTRAVIA CONTAINER EMPTY; CONTAINER, I.V.

Catalog Number 2B8011

Device Problems Break (1069); Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that it was difficult to remove an intravia container empty from tubing, and the bag broke during removal.The reporter stated forceps were used to remove the part of the bag stuck to the tubing.It was not specified when in the process this event occurred.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed and it was observed that the membrane tube assembly was detached from the bag.A functional test was performed and the bag was submerged underwater and no leakage was observed.The reported condition was verified.The cause of the reported condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTRAVIA CONTAINER EMPTY
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina, san cristobal
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7541733
• MDR Text Key: 109282055
• Report Number: 1416980-2018-03148
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2023
• Device Catalogue Number: 2B8011
• Device Lot Number: DR18A03085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2018
• 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