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

Catalog Number	2J8003
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot #: dr17e27052, dr18b13066, and dr18e24082.One single-use device was received for evaluation.A visual inspection was performed and it was noted that there was a hole in the bag near the injection site.Under water pressure testing was performed and a leak was identified near the seam of the injection site.The reported condition was verified.The cause of the reported condition was undetermined.Seven (7) companion samples were also received for evaluation.Visual inspection was performed on the companion samples and no visual defects were noted, all components are correctly placed and according to specification.Functional leak and pressure testing were performed with no issues noted.The reported condition was not verified through companion sample evaluation.A batch review was conducted for the three reported lots and there were no deviations found related to this reported condition during the manufacture of the lots.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
This report summarizes 4 malfunction events.It was reported that at least four (4) intravia containers 500 ml were leaking.Two (2) containers were leaking from the port, one (1) container was leaking from the bottom seam, and an unspecified quantity of containers were leaking from unspecified locations.Of the four events, three occurred prior to patient use and in one event it was not specified if there was patient involvement.No additional information is available.

• Brand Name: INTRAVIA CONTAINER EMPTY
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina, san cristobal
• MDR Report Key: 8287309
• Report Number: 1416980-2019-00364
• Device Sequence Number: 1587729
• Product Code: KPE
• UDI-Device Identifier: 00085412029566
• UDI-Public: (01)00085412029566
• Combination Product (Y/N): N
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: 2J8003
• Device Lot Number: SEE H10
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2018
• Initial Report FDA Received Date: 01/29/2019
• Patient Sequence Number: 1