MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® ADMINISTRATION SETS WITH AIR-ELIMINATING FILTER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7333-24
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter's complete.(b)(6).
Event or Problem Description
It was reported that air passed through the filter of a cadd® administration sets with air-eliminating filter.An air bubble was found past the air filter.A peripherally inserted central catheter was used for vein access.No injury was reported.
Additional Manufacturer Narrative
One used product sample was returned to smiths medical.The examination of the returned sample showed no abnormalities.The returned sample was given functional testing: this showed no leaking or air bubbles occurring in the line.The reported issue could not be duplicated during testing.The manufacturing facility performed a review of the manufacturing process.The review showed that assembly process was being performed as per procedure.The review also showed the quality inspection performed after assembly process was also being performed as per procedure.The manufacturing facility also performed an in-process visual inspection of 32 products that were in the assembly area: this inspection showed no issues with the products being assembled.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: CADD® ADMINISTRATION SETS WITH AIR-ELIMINATING FILTER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6772072
• Report Number: 3012307300-2017-01707
• Device Sequence Number: 1371095
• Product Code: FPA
• UDI-Device Identifier: 10610586043239
• UDI-Public: 10610586043239
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2018

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: 04/11/2022
• Device Catalogue Number: 21-7333-24
• Device Lot Number: 47X235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 08/07/2017
• Supplement Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1