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

Catalog Number 21-7036-01

Device Problems Leak/Splash (1354); Insufficient Flow or Under Infusion (2182)

Patient Problems Complaint, Ill-Defined (2331); Underdose (2542)

Event Date 06/30/2016

Event Type  Injury  

Manufacturer Narrative

Voluntary medwatch form #: mw5066840.The reporter noted the incident occurred in summer 2016.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that a cadd® administration set had an issue of serious underinfusion and leaking.The underinfusion was between 15% and 56%, and the patient was compromised and needed additional care.The patient required higher levels of monitoring.It was unclear what the impact to the patient was.See mfr: 3012307300-2017-00467, 3012307300-2017-00468, 3012307300-2017-00469, 3012307300-2017-00470, 3012307300-2017-00471, 3012307300-2017-00472, 3012307300-2017-00473, 3012307300-2017-00474, 3012307300-2017-00475, 3012307300-2017-00476, and 3012307300-2017-00477.

• 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: 6339094
• MDR Text Key: 67702113
• Report Number: 3012307300-2017-00472
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020186
• UDI-Public: 10610586020186
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 21-7036-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention