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

Catalog Number	21-7036-01
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the medication bag was full and although the pump acknowledged that the fluid was running, no fluid was coming out of the smiths medical cadd administration set.The reporter indicated that the staff tried to bolus the fluid when not connected to the patient, but no fluid came out of the tubing.Subsequently, another set of tubing was primed and used with no issues identified.The impact of the reported issue was that the patient ended up not receiving her pain medication and was in pain, unnecessarily.No further adverse effects were reported.
Additional Manufacturer Narrative
Device analysis: one smiths medical cadd administration set was returned for analysis in a used condition.The sample was visually inspected under normal conditions of illumination and no obstructions were detected in any of the joins of the product.Functional testing was performed by making distilled water pass through the sample received using a syringe to look for unusual function.The water flowed through the whole product; the test was passed successfully.Based on the evidence, the complaint was not confirmed, and no fault 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: 8874011
• Report Number: 3012307300-2019-03979
• Device Sequence Number: 11292572
• Product Code: FPA
• UDI-Device Identifier: 10610586020186
• UDI-Public: 10610586020186
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K933390
• 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
• Report Date (Section B): 09/10/2019

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: 03/11/2024
• Device Catalogue Number: 21-7036-01
• Device Lot Number: 3773526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1