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

Catalog Number 21-7220-24

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/25/2021

Event Type  Injury  

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review(dhr).Six units were received for evaluation; the returned units were received in decontaminated condition without their original packaging.Visual and functional testing were performed.Samples received did not present with any damaged, broken, or bent in the canula section.Retractor was tested using an insertion pad for each sample received, to see if the spring is activated and if it adhered the insertion of the needle.The insert was adhered correctly on the insertion pad and there was not any defect in the returned samples.Complaint could not confirm.Based on the samples unused returned for the evaluation was not possible replicate the issue, based in the dhr and in process inspection controls 200 parts were tested with no issues reported.A corrective and preventative action (capa) has been opened to address the reported issue.Root cause identified per capa: cannulas can be detaching due to an inadequate processing per a shift on parameter window for the cannula molding process.Actions were taken to mitigate the reported issue: achieve tool consistency, perform process validation, develop and validate cannula strength tensile test to ensure cannula can meet minimum tensile strength.

Event Description

It was reported that the device was breaking off and a piece would stay under the patient's skin.The broken piece was not able to be found while trying to remove it.

• Brand Name: CADD CLEO INFUSION SETS
• Type of Device: 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: 16899384
• MDR Text Key: 314885004
• Report Number: 3012307300-2023-05432
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586028335
• UDI-Public: 10610586028335
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-7220-24
• Device Lot Number: 3860542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male