MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CLEO INFUSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7230-24
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Malfunction
Event or Problem Description
It w reported that after two boxes in use, which the patient did very well with, significant allergic reactions occurred.No medical or surgical intervention was reported.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problem or issues were identified during the device history record review.Ninety-four samples were received for evaluation; 60 decontaminated with its original closed shelf carton and 34 samples in new condition with its original open package.During visual inspection, no defects were found in the 94 samples.In order to reproduce the failure mode reported by the customer, two cannulas were placed in two different people with the aim of reviewing any reaction in the skin.No reaction was observed in either person.Production personnel performs 100 percent visual inspection using a black light in order to verify that drop has been placed at each joint and the amount of adhesive is correct.According to the procedure, production personnel verify the alignment and position of the adhesive with the cannula and that the central portion of the adhesive does not show any damage.Production personnel takes a sample of four (4) at start up, the beginning of every job and at least every (3) hours according with the procedure and performs testing.Also, according to the procedure quality takes a sample size that is determined daily based on the expected output and dividing the sample size so that a proportional amount is inspected at a 1 hourly intervals with an accept or reject criteria.Quality audits the adhesion testing of the skin adhesive and the pull testing of tubing set, at start up and at least every (3) hours, in order to verify there are none that are abnormal and have met within specification.After sample evaluation, the complaint was not confirmed.No corrective actions were taken.

• Brand Name: CADD CLEO INFUSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16891984
• Report Number: 3012307300-2023-05363
• Device Sequence Number: 6162698
• Product Code: FPA
• UDI-Device Identifier: 10610586028397
• UDI-Public: 10610586028397
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2023

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: Lay User/Patient
• Device Expiration Date: 01/04/2026
• Device Catalogue Number: 21-7230-24
• Device Lot Number: 4091366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown