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

Model Number	21-7081-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in (b)(6) but was reported by the u.S site.Related mfr numbers are : 3012307300-2019-06191, 3012307300-2019-06192.
Event or Problem Description
Information was received indicating that the cadd administration set leaked was found leaking during infusion.The leak was noticed from the stinging cap of the "y".There was no reported injury to the patient.
Additional Manufacturer Narrative
Returned device was received and leak testing was performed.No leaks were detected when testing the returned sample.No discrepancy was found with the returned product.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
Additional Manufacturer Narrative
Two cadd administration sets - non flow stop samples were returned for analysis.One sample was too contaminated and was unable to be decontaminated in order to be analyzed and was disposed of.The other sample was able to be investigated.The sample was visually inspected at a distance of 12" to 16" under normal conditions of illumination.The sample was received cut from the tube connected to inj.Site to male luer.Leak testing on the sample received was performed using a syringe to look for unusual functions.No discrepancies were detected; test successfully passed.Per previous complaints a review of the manufacturing process was conducted by quality engineer in order to verify that there are no situations or practices that could create the event as described.During the manufacturing process, production personnel do a visual inspection before a process (assemble, bond, etc.) to ensure that the material is in perfect shape; also right after a work station, personnel redo an inspection in order to find any discrepancies.Quality takes a sample of 15 units at an interval of two (2) hours, prior to placing product in bag, in order to verify that parts are free of damage (scuffs, pinch marks, etc.), cracks, crazing, cuts, or other workmanship defects that can affect assembly function or appearance.The cause of the issue cannot be determined since the complaint was not confirmed due to the fact that the sample was successfully tested and no discrepancies as the reported was found.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9292723
• Report Number: 3012307300-2019-06193
• Device Sequence Number: 14031086
• Product Code: FPA
• UDI-Device Identifier: 10610586021480
• UDI-Public: 10610586021480
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K991599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2020

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: 21-7081-24
• Device Catalogue Number: 21-7081-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 01/23/2020; 01/23/2020
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 05/06/2020; 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1