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

Catalog Number	21-7232-24
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).No problem or issues were identified during the device history record review.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that the cannula/hub was not releasing from the insertion piece/not sticking to the skin/tegaderm.Ten 10 boxes of the product from the affected lot was set to the side.I also have 2 of the defective soft sets saved, (1 where the needle is visibly bent, and 1 where the adhesive dot did not separate from the applicator).Normally, part of the device is applied using a small needle to insert a similarly small and soft cannula under the skin as part of the insertion process the external portion of the device is secured to the skin using adhesive.Both issues with the device described above (bend needle and adhesive dot not releasing from the applicator) prevented the device from being inserted/applied successfully.At this time, it did not appear that any patients were harmed due to these defects.Additional information received via email, nurse noted that after 2 attempts to insert a soft set that the adhesive for the cannula/hub was not sticking to the patient.Soft set insertion piece inspected on a third unit and noted that the needle was bent.Other soft sets from the same box checked by nurse and several noted to have bent needles.They have experienced the issue with cannula/hub not releasing from the insertion piece/not sticking to the skin/tegaderm with other units where there was no issue with bent needles.No patient injury reported.

• Brand Name: CADD CLEO INFUSION SETS
• Common Device Name: SET, ADMINSTRATION, 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: 16790780
• Report Number: 3012307300-2023-04383
• Device Sequence Number: 5679185
• Product Code: FPA
• UDI-Device Identifier: 10610586028410
• UDI-Public: 10610586028410
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2023

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: Health Professional
• Device Catalogue Number: 21-7232-24
• Device Lot Number: 4213341
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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