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

Catalog Number 21-7036-01

Device Problems Leak/Splash (1354); Material Integrity Problem (2978)

Patient Problems Complaint, Ill-Defined (2331); Missed Dose (2561)

Event Date 09/25/2016

Event Type  Injury  

Manufacturer Narrative

Voluntary medwatch submission #: mw5066816.One cadd® administration set was returned for evaluation without original packaging.Visual inspection found excess solvent at the bond between the pump tube and pressure plate where leakage was caused.A review of the testing and inspection documents was conducted and found adequate.A review of the manufacturing process found all procedures were being carried out appropriately.Functional testing involved a simulated use test of a sample product with excess solvent and showed that the described issue was replicated.Based on the evidence, the root cause of the issue is attributed to the excess solvent during the bonding process and missing the excess solvent during inspection.

Event Description

It was reported that a cadd® administration set tubing was leaking and was almost completely severed at the distal end of the cassette.The incident caused the patient to miss one dose of "pip/taz 4.5g iv q 6h".It was unclear what the impact to the patient was.

• 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: 6304452
• MDR Text Key: 66617723
• Report Number: 3012307300-2017-00410
• 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
• 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 Expiration Date: 07/28/2021
• Device Catalogue Number: 21-7036-01
• Device Lot Number: 46X490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2016
• 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