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 10/04/2016

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.

Event Description

It was reported that a cadd® administration set tubing was leaking medication at the cassette site.It was unclear what the impact to the patient was.

Manufacturer Narrative

One cadd® administration set was returned for evaluation.The sample was received inside a plastic bag and without its original packaging.The returned sample was visually inspected and this showed a partial detachment of the tubing between the pump tube and the pump pressure plate.An attempt to replicate the detachment on in-process administration sets found that the detachment could be replicated if an excessive amount of adhesive was used to bond the pump tube to the pump pressure plate.A review of the manufacturing process was conducted for a product similar to the reported device.Review found that the assembly process was conducted according to the procedures.The manufacturing facility also performed an in-process visual inspection of 32 products that were in the assembly area: this inspection no excess solvent was identified with the products.Investigation determined that the root cause of the detachment was manufacturing.The most probable causes were excess solvent being applied to the sample and/or the delamination or bonding issue was identified during inspection.

• 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: 6304652
• MDR Text Key: 66615371
• Report Number: 3012307300-2017-00419
• 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: 05/02/2017

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: 11/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2017
• 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