MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NRFIT CONNECTOR SET; SET, I.V. FLUID TRANSFER

Model Number	21-7605-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during the use of the product, leakage of medical fluid from the connection part (where the tubing and the mediation bag were connected) was observed." no patient injury was reported.*no additional information is available for this complaint.
Additional Manufacturer Narrative
A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.
Additional Manufacturer Narrative
H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection results: the sample don't present any damage, scuffs, pinch marks, cracks, crazing, cuts, etc.Could cause the failure mode reported (see picture below).Leak test results: the sample was analyzed using a syringe with colored water to detect any leaks.Results: during the test sample, a leak were found between the filter and tube.The complaint is confirmed.Root cause identified in the process was lack solvent to don't follow up procedure mp-366 rev.112 extension set with filter assembly section 12.0 bond coiled tube assembly to filter inlet.The cause of the reported problem was traced to the manufacturing process.The lot 4196364 was manufactured with (b)(4) units, lot met the requirements to release the lot with no deviations identified during their manufacturing process.

• Brand Name: NRFIT CONNECTOR SET
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-1-1 akasaka; minneapolis, MN 55442
• MDR Report Key: 14111662
• Report Number: 3012307300-2022-06374
• Device Sequence Number: 20155791
• Product Code: LHI
• UDI-Device Identifier: 10610586044113
• UDI-Public: 10610586044113
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: 10/22/2023
• Device Model Number: 21-7605-24
• Device Catalogue Number: 21-7605-24
• Device Lot Number: 4196364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown