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

Catalog Number 21-7036-01

Device Problem Leak/Splash (1354)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/07/2016

Event Type  Injury  

Manufacturer Narrative

Voluntary medwatch submission #: mw5066816.The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.Device evaluation in progress.

Event Description

It was reported that a cadd® administration set tubing was leaking where it connected to the distal end of the cassette.It was noted that the bag that the pump was in was soaked with fluid.It was unclear what the impact to the patient was.

Manufacturer Narrative

One cadd® 0.2 fltr spike administration set was returned for investigation.The sample was received inside a plastic bag and without its original packaging.Additionally, photographs were provided for examination; no leakage was noted during review of the photographs.Visual inspection of the returned sample was conducted at a distance of 12" to 24" and under normal conditions of illumination.During examination, a crack was found in the star tubing.Investigation determined that the observed crack was a result excessive solvent application during manufacturing.

• 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): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6304610
• MDR Text Key: 66615629
• Report Number: 3012307300-2017-00409
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K933390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-7036-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability