MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NRFIT, CADD ADMINISTRATION SETS - FLOW STOP; SET, I.V. FLUID TRANSFER CADD CASSETTE RESERVOIRS

Model Number	21-7624-24
Medical Device Problem Codes	Complete Blockage (1094); Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.Visual inspection and functional testing were performed on three pictures received and one sample returned.During the analysis conducted it was observed at the top view of the product with their respective pouch in the first picture; the other angles are focused on the pump tube which marks are visible, however, it is not possible to confirm the failure mode since no obstruction neither occlusion are visible.No discrepancies were detected, the whole set could be primed and once was set, there are no discrepancies were detected, the failure mode was not confirmed.No corrective actions are required since the complaint was not confirmed.
Event or Problem Description
It was reported that when the suspect device was not functional after being attached to the cassette.There was no further information provided by the customer, however; no patient injury was reported.
Additional Manufacturer Narrative
Other, other text: while performing a review of submitted mdr report it was discovered that this file was inadvertently assessed as reportable.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.Report 3012307300-2022-08590 is no longer considered reportable, please disregard any mdr reports associated with it.

• Brand Name: NRFIT, CADD ADMINISTRATION SETS - FLOW STOP
• Common Device Name: SET, I.V. FLUID TRANSFER CADD CASSETTE RESERVOIRS
• 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; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 14365947
• Report Number: 3012307300-2022-08590
• Device Sequence Number: 17556042
• Product Code: PWH
• UDI-Device Identifier: 10610586044748
• UDI-Public: 10610586044748
• 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,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022

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
• Device Expiration Date: 12/14/2021
• Device Model Number: 21-7624-24
• Device Catalogue Number: 21-7624-24
• Device Lot Number: 3915927
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/19/2021
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0148-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown