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

Catalog Number 21-7324-24

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun, as the device is currently in transit to the investigation site.

Event Description

It was reported that a cadd® administration set had a hole in the tubing and was leaking.The reporter notes that the pump used at the time of the event created the hole in the tubing.Liquid leaked out of the tubing and onto the pump, damaging the pump.No injury was reported.See mfr: 3012307300-2017-01196.

Manufacturer Narrative

Smiths medical received one cadd® administration set was returned for analysis in a used condition.Upon visual examination a cut was found in the pump tube.Documents were reviewed and deemed adequate and correct with respect to testing and inspection.A review of production was performed and a random sample of (b)(4) units was examined prior to packaging with no damage noted to tubing.Leak and pull testing was performed on the four random units with no discrepancies found.Based on the evidence the complaint was confirmed.The most probable root cause was found to that the tubing was damaged after it left the manufacturing facility, due to the fact the defect mentioned on this report is easily detectable by the inspection and leak test.

• Brand Name: CADD® ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; 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: 6609181
• MDR Text Key: 76599182
• Report Number: 3012307300-2017-01195
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029653
• UDI-Public: 10610586029653
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/26/2021
• Device Catalogue Number: 21-7324-24
• Device Lot Number: 46X891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1