MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	7N8377
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/03/2017
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 a one-link set did not properly connect to a catheter.This occurred before use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
One device was received for evaluation.During visual inspection, it was noted no extension was returned.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Clear passage, pressure and functional testing were all completed and the device performed according to product specifications.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: EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina san cristobal
• MDR Report Key: 7277058
• Report Number: 1416980-2018-00817
• Device Sequence Number: 1276210
• Product Code: FPA
• UDI-Device Identifier: 00085412091808
• UDI-Public: (01)00085412091808
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K132734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2018

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: 07/12/2022
• Device Catalogue Number: 7N8377
• Device Lot Number: DR17F24024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1