MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO IVT DISPOSABLE; CONTAINER, I.V.

Catalog Number 2B8011

Device Problems Break (1069); Failure to Disconnect (2541); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the nurse was unable to remove the spike of an unknown secondary iv line from an intravia empty bag.The bag had been filled with unknown antibiotics.The reporter stated that a ¿piece of the antibiotic bag broke off the bag and stayed attached to the spike of the secondary tubing.¿ this occurred during patient use.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).Only the port of the actual sample was received for evaluation.Visual inspection revealed that the port was torn apart from the bag.The reported condition was confirmed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The torn apart port was not received with the rest of the bag.The torn apart port was determined to be due to the user experiencing difficulty in removing the spike from the bag's port.The cause of the difficulty was unable to be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: IVT DISPOSABLE
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3728207
• MDR Text Key: 4327679
• Report Number: 1416980-2014-11071
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2B8011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2014
• 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