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

Catalog Number 21-7034-24

Device Problem Leak/Splash (1354)

Patient Problem Missed Dose (2561)

Event Date 07/14/2017

Event Type  malfunction  

Event 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 Description

No medical intervention was required.No patient injury was reported.

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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 6773799
• MDR Text Key: 82046821
• Report Number: 3012307300-2017-01725
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020162
• UDI-Public: 10610586020162
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K895046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/22/2021
• Device Catalogue Number: 21-7034-24
• Device Lot Number: 46X949
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other