MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO 90 SUBCUTANEOUS; SET, ADMINISTRATION,

Model Number	21-7222-24
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the while removing the needle, short tube was no longer palpable.It could not even be felt at the patient anymore.No patient injury reported.
Additional Manufacturer Narrative
Samples received by shm: the samples consist of five (5) products.Four (4) samples were received in unused conditions without their original package and one (1) sample was received in used condition without its original package.Visual inspection: the samples were visually inspected, at a distance of 12? to 24? and normal conditions of illumination.Results: four (4) samples has the retractor inactive in unused conditions.One (1) sample has the cannula broken.Other analysis due to the fact there was no lots were programed to be manufactures in the near future, a review of the manufacturing process for them was conducted by quality engineer on (b)(6) 2019 in order to verify that there are no situations or practices that could create the event as described in ?description of non-conformance?.Both part numbers belong to the cleo product family and are manufactured with the same process, procedures and controls.However the one has a 42? buckle while the other has a 24? buckle.During the verification the following operations were reviewed: line clearance record was reviewed; no discrepancies were observed.Inserter assembly operation was audited by the quality engineer and it was performed by the production personnel according to the manufacturing procedures.Training records were reviewed, operators are trained on operation been performed.Maintenance records from ?site threader? machine were reviewed; no anomalies were detected.Functional test was performed as follows: three (3) samples were taken from cleo production line and tested; after removing the white cap the site was inserted into the insertion pad.The inserted cannula was twisted around and pulled from the insertion pad, in neither of the worse test cases produced can cause the cannula to brake or detach.Results: no detachment was detected in any of the tested samples and the cannula was not remove from the site.Mitigation: the retractor assemblies are 100% visually inspected by the production personnel to assure that the needle is properly threaded.Qc performs an in process audit at 1 hour intervals to verify that needle is properly threaded on the retractor assemblies.Root cause: the customer reported: ?while removing the needle, short tube was no longer palpable? in order to perform a complete root cause analysis of this failure mode, corrective and preventative action was open on (b)(6) 2017.Action taken: corrective and preventative action was open on (b)(6) 2017 in order to implement corrective actions for this failure mode.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CLEO 90 SUBCUTANEOUS
• Common Device Name: SET, ADMINISTRATION,
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15680161
• Report Number: 3012307300-2022-26344
• Device Sequence Number: 12372918
• Product Code: FPA
• UDI-Device Identifier: 30610586028353
• UDI-Public: 30610586028353
• 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: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2022

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 Model Number: 21-7222-24
• Device Catalogue Number: 21-7222-24
• Device Lot Number: 3630814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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