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

Catalog Number	7N8391
Medical Device Problem Codes	Disconnection (1171); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
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 the tubing of an unspecified quantity of one-link non-dehp standard bore catheter extension sets were loosening and disconnecting.No leaks were observed.This issues was identified during priming with 0.9% sodium chloride 10ml flush prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
D4: expiration date is "ni", previously submitted as "01/04/2026".H4: the lot was manufactured from january 04, 2021 - january 05, 2021.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All components were correctly placed and according to specifications.A functional testing was performed including clear passage and pressure testing; and the results were satisfactory.Additional priming was performed and no issues noted.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.
Additional Manufacturer Narrative
Correction: b4/f8: date of this report in the initial mdr is being corrected from blank to 06/04/2021.

• Brand Name: EXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11940044
• Report Number: 1416980-2021-03359
• Device Sequence Number: 11726606
• Product Code: FPA
• UDI-Device Identifier: 00085412475400
• UDI-Public: (01)00085412475400
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K132734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2021

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: 01/04/2026
• Device Catalogue Number: 7N8391
• Device Lot Number: R21A04096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 06/23/2021; 07/01/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/06/2021; 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1