MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NRFIT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7605-24
Date of Event	09/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number is currently unavailable.
Event or Problem Description
Information was received indicating that complained of pain and it's possible that medication has not been passing through the cadd extension set.There were no adverse events reported.
Additional Manufacturer Narrative
Two pictures of a cadd extension set were received for evaluation.The picture showed one cassette product and a cassette extension set with a broken female luer.One cadd cassette product from part number 21-7605-24 and unknown lot number and one cassette extension tube was received.The sample was visually inspected, at a distance of 12? to 24? and normal conditions of illumination.The cassette extension tube had a piece of yellow cap inside of the female luer.The sample could not be functionally tested because of this condition.A 21-7006-24 product was used to perform a yellow cap assembly manually; the yellow cap could not break in manual assembly even when applying excessive force.The assembly between the female luer and yellow cap was fixed to a press to make it possible to apply more force in assembly.The yellow cap could be broken when fixed to the press, however this is not normal use conditions for the dispositive.The yellow cap presented deformations at the moment to fix to the press.The failure mode could not be replicated, therefore the root cause is not attributable at the manufacturing process.

• Brand Name: NRFIT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10589227
• Report Number: 3012307300-2020-09833
• Device Sequence Number: 19146779
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 21-7605-24
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 11/29/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No