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

Catalog Number	21-7034-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Missed Dose (2561)
Date of Event	07/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tubing of a cadd® administration set leaked during the patient's treatment.The patient went to the emergency room "for disconnect" and did not receive the drug.No permanent injury was reported.
Event or Problem Description
No medical intervention was required.No patient injury was reported.
Additional Manufacturer Narrative
No device was returned for evaluation.Photos were returned for examination.Photographic inspection found two solvent bonds, with marks denoting the leak path.A review of the testing and inspection documents was performed and deemed adequate and correct.A review of the manufacturing process was performed on a similar part and found no discrepancies.Visual inspection of (b)(4) devices from the production floor was performed and found no discrepancies.Leak and pull testing was performed on (b)(4) samples from production and passed successfully.Based on the evidence, a root cause was unable to be determined.

• 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: 6773799
• Report Number: 3012307300-2017-01725
• Device Sequence Number: 18866728
• Product Code: FPA
• UDI-Device Identifier: 10610586020162
• UDI-Public: 10610586020162
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K895046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/22/2021
• Device Catalogue Number: 21-7034-24
• Device Lot Number: 46X949
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 08/14/2017; 04/02/2018
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 09/12/2017; 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other