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

Catalog Number	21-7375-24
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: (b)(6).
Event or Problem Description
Information was received that the cadd extension was leaking at the hose connector.Unfortunately, the patient did not notice this until after about 3 hours when he raised his backpack while going to bed and the pe solution had swum towards him.No reported adverse effects.
Additional Manufacturer Narrative
According to the investigation two pictures were received and the product appeared outside its package, which was the asv valve detached from the tube.The sample consist of one product from p/n 21-7375-24 l/n 3607883.The returned sample was received in used conditions inside a plastic bag without its original packaged.The sample was visually inspected at a distance of 12" to 24" under normal conditions of illumination.The sample was received with the asv valve loose and no solvent was found on the tube, nor the asv valve.The customer's reported problem was confirmed.According to the investigation the most probable root causes of the reported issue are, the operator did not applied solvent in the bonding between the spike and the tube or the solvent pots do not show a solvent level.According to the investigation, these actions were taken per previous complaints, investigation open in order to implement the replacement of current solvent pots by solvent dispensers.Quality alert was released as awareness that production personnel should be perform a verification of the container levels and it show them the differences between a tube with solvent and one without production personnel were trained in order to reinforce the bonding operation.

• 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: 8364935
• Report Number: 3012307300-2019-00789
• Device Sequence Number: 1826108
• Product Code: FPA
• UDI-Device Identifier: 10610586027444
• UDI-Public: 10610586027444
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: No Information
• Device Expiration Date: 04/24/2023
• Device Catalogue Number: 21-7375-24
• Device Lot Number: 3607883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 02/24/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1