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

Catalog Number	21-7021-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that a cadd® administration set was found to be leaking "medical fluid" during use.No injury was reported.
Additional Manufacturer Narrative
One device was returned for evaluation in unused condition and without its original packaging.Visual inspection of the device found that there was delamination of the solvent bond between the pump tube and tubing.Functional testing involved a leak test and found that the device leaked at the solvent bond.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.Leak and pull testing was performed on 4 sample devices and found no discrepancies or leaks.Based on the evidence, the root cause was attributed to a manufacturing issue.
Additional Manufacturer Narrative
One device was returned for evaluation in unused condition and without its original packaging.Visual inspection of the device found that there was delamination of the solvent bond between the pump tube and tubing.Functional testing involved a leak test and found that the device leaked at the solvent bond.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.Leak and pull testing was performed on 4 sample devices and found no discrepancies or leaks.Based on the evidence, the root cause was attributed to a manufacturing issue.For all enquires or follow up questions related to the record, do not use (b)(6) located in section g1, please direct those to the following: (b)(6) corrected data: g7: follow-up number.

• 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
• Manufacturer (Section G): NULL; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6585093
• Report Number: 3012307300-2017-01073
• Device Sequence Number: 78728
• Product Code: FPA
• UDI-Device Identifier: 10610586019760
• UDI-Public: 10610586019760
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K895046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2017

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
• Device Catalogue Number: 21-7021-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 10/12/2017; Not provided
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 03/12/2024; 10/31/2017
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown