MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC ALL-IN-ONE CONTAINER; CONTAINER, I.V.

Catalog Number	2B8114
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that when the blue cap of an all-in-one container was twisted to insert tubing from a solution bag, the entire port came off and solution spilled.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.During visual inspection it was noted that the twist off protector was missing from the set.The reported condition was verified.The cause of the reported condition was lack of solvent applied between junction of tubing to the twist off protector during manufacturing.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: ALL-IN-ONE CONTAINER
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina san cristobal
• MDR Report Key: 7284177
• Report Number: 1416980-2018-00908
• Device Sequence Number: 1177511
• Product Code: KPE
• UDI-Device Identifier: 00085412043869
• UDI-Public: (01)00085412043869
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K090096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2018

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: Health Professional
• Device Expiration Date: 09/08/2022
• Device Catalogue Number: 2B8114
• Device Lot Number: DR17I05050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1