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

Catalog Number	21-7061-24
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical flex tubing when using a cadd legacy pump found that the tubing was wet.It was discovered that the tube was crooked and only held at the end of the connector.There was no reported adverse events due to this issue.
Additional Manufacturer Narrative
Device evaluation: one smiths medical cadd extension set along with one smiths medical cadd medication cassette were returned for analysis in used condition.Visual inspection showed that the male luer of the extension set was cut and the tube was damaged.No discrepancies were found on the cadd medication cassette.Functional testing involved attaching a new luer to the extension set and performing a leak test.The sample was fully primed and connected without difficulty and no alarm or leaking was detected in either the cadd medication cassette or extension set during the investigation.A review of manufacturing processes was performed.It was verified that procedures in the assembly process and quality check process were being properly followed.Based on the investigation, the complaint allegation was not confirmed.Updated: concomitant medical products, device evaluated by mfr, and adverse event problem.

• Brand Name: CADD EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9145597
• Report Number: 3012307300-2019-04979
• Device Sequence Number: 19589150
• Product Code: FPA
• UDI-Device Identifier: 10610586020445
• UDI-Public: 10610586020445
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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: 04/19/2018
• Device Catalogue Number: 21-7061-24
• Device Lot Number: 3607921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 11/10/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1