MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	ACT5612
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there were holes in the tubing of four (4) extension sets which caused fluid to leak onto the floor.The leaks were discovered during preparation.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
(b)(4).The actual devices were not available; however, forty-four (44) companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed, including pressure and clear passage under water, with no issues noted.The reported condition was not verified on the companion 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.

• Brand Name: EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 8651932
• Report Number: 1416980-2019-02949
• Device Sequence Number: 16881085
• Product Code: FPA
• UDI-Device Identifier: 00085412079714
• UDI-Public: (01)00085412079714
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K142011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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?: Yes
• Operator of Device: Other
• Device Catalogue Number: ACT5612
• Device Lot Number: R18I17179
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1