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

Model Number 21-7391-24

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2019

Event Type  malfunction  

Event Description

Information was received indicating that during use of this smiths medical cadd administration sets, leaking was noticed.It was reported that the sets "luer connection was not fitting (to small) to pivc, bung or another connector caused leakage".Reported that there was no patient involvement.

Manufacturer Narrative

Other, other text: a sample was received to perform an investigation.The sample was visually inspected at a distance of 12 to 16 inches under normal conditions of illumination.The anti-siphon valve (asv) from the sample received was compared with a product floor sample and found that the nozzle from the valve of the returned sample was bigger.A device history record (dhr) review was performed which indicated all inspections were completed and no issues were noted during manufacture.The most probable root cause was that the asv was received defective from the supplier.A supplier corrective action report (scar) was issued to address possible causes.This remediation mdr was generated under protocol (b)(4).As a result of warning letter cms# (b)(4).

• Brand Name: CADD ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 9522185
• MDR Text Key: 177230077
• Report Number: 3012307300-2019-07003
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027512
• UDI-Public: 10610586027512
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2024
• Device Model Number: 21-7391-24
• Device Catalogue Number: 21-7391-24
• Device Lot Number: 3776291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1