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

Model Number SET, ADMIN, CADD, 94", SPIKE, 0.2 FLTR, COILED TUBE, FS,

Device Problems Obstruction of Flow (2423); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  Injury  

Event Description

Information received a smiths medical cadd administration set tubing would not prime and stopped around air filter.Pump alarm displayed downstream occlusion.Two sets tried and the third set worked.Patient was receiving home visit with administration of vancomycin intravenous.No patient adverse events, as this would be a delay in therapy.

Manufacturer Narrative

One endotracheal tube was returned for evaluation.Visual inspection of the device found it to be in good physical condition.The cuff of the returned sample was inflated using a syringe and the product was submerged under water in order to detect any leakage; leak observed between valve and pilot balloon.The bell-out, fit inflation line and leak test operations were audited during 32 units, in order to verify that the operations were properly performed.No discrepancies were detected.The reported customer complaint has been confirmed, and the problem source determined to be either that solvent was missing between pilot balloon and valve, or a lack of detection by production personnel.

Event Description

Information was received that the tube was changed out as a result.This incident is now a serious injury as this constitutes medical intervention.

• Brand Name: CADD ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 lane n; minneapolis MN 55442
• MDR Report Key: 9539712
• MDR Text Key: 174964187
• Report Number: 3012307300-2020-00604
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161953
• UDI-Public: 15019517161953
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2024
• Device Model Number: SET, ADMIN, CADD, 94", SPIKE, 0.2 FLTR, COILED TUBE, FS,
• Device Catalogue Number: 21-7346-24
• Device Lot Number: 3793888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Date Manufacturer Received: 03/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1