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

Catalog Number	2J8003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Twenty-two (22) samples were received for evaluation.Six of the returned samples were found to have rough/dried out injection ports.Four of the returned samples were found to have rough/dried out injection ports, and the injection ports were also separated from the bags.The reported condition was verified for ten of the received samples.The cause of the condition was not determined.Visual inspection on the other twelve samples did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified for twelve of the returned samples.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.
Event or Problem Description
It was reported that the injection port of twenty-two (22) intravia containers were broken.The issue was further described as rubber coming out when the needle is withdrawn from the bag following filling of the container with medication.This event was observed prior to patient use.There was no patient involvement.No additional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: 7856348
• Report Number: 1416980-2018-05714
• Device Sequence Number: 16426520
• Product Code: KPE
• UDI-Device Identifier: 00085412029566
• UDI-Public: (01)00085412029566
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 2J8003
• Device Lot Number: DR17K29073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1