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

Catalog Number 21-7036-01

Device Problem Break (1069)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 11/07/2016

Event Type  Injury  

Manufacturer Narrative

Voluntary medwatch submission #: mw5066839 and mw5066842.18-90 years old; 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 broke where it attached to the filter.Due to the incident, some of the antibiotic leaked onto the patient's clothes following the dose administration.It was unclear what the impact to the patient was.

Manufacturer Narrative

One used cadd® administration set was returned for investigation along with a photograph of the device.The device history record was reviewed and no discrepancies were found.A visual inspection was performed and the bonded connection of the extension tube with the filter was missing as a result of a detachment of the filter outlet.A manufacturing review of a similar device was performed and no discrepancies were found.The root cause of the fault was determined to be that the filter broke after leaving the manufacturing facility.The complaint was confirmed.

• 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, 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6390862
• MDR Text Key: 69483792
• Report Number: 3012307300-2017-00659
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Catalogue Number: 21-7036-01
• Device Lot Number: 46X475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2016
• 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
• Patient Outcome(s): Hospitalization; Other; Required Intervention