MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTRAVIA CONTAINER EMPTY; CONTAINER, I.V.

Catalog Number 2B8019

Device Problems Crack (1135); Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the ports of the unspecified quantity of 50ml intravia empty containers were cracked and falling out during spiking chemotherapy drugs.These issues were identified prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information : the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed and noted four (4) devices; however, no damage was observed on the photo samples.The reported condition was not verified.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 CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9306278
• MDR Text Key: 166398106
• Report Number: 1416980-2019-06241
• Device Sequence Number: 1
• Product Code: KPE
• UDI-Device Identifier: 00085412003504
• UDI-Public: (01)00085412003504
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2B8019
• Device Lot Number: DR19D02049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/03/2019
• 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