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

Event Date 11/25/2016

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 was leaking at the joint of the tubing after the cassette.At 21:09 on the date of event, it was observed that the pump bag was soaked.It was suspected that the patient had a missed dose at 20:00.The tubing was changed at an outpatient center.It was unclear what the impact to the patient was.

Manufacturer Narrative

One used cadd® administration set was returned for investigation.A visual inspection was performed to look for damage, cuts, holes, or anything that could cause a leak.During inspection, delamination was found in the bonding union with the pump tube and the 12" extension tube.Functional testing was performed, and the device leaked on the bonded joint between the pump tube and 12" tube.A manufacturing review of a similar device was performed and no discrepancies were found.The most probable root cause was determined to be that the manufacturing production personnel did not verify that the solvent bond between the tubes did not have any delamination or voids.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: 6390868
• MDR Text Key: 69482687
• Report Number: 3012307300-2017-00661
• 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

• 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: 01/12/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2017
• Initial Date FDA Received: 03/09/2017
• Supplement Dates Manufacturer Received: 08/08/2017
• Supplement Dates FDA Received: 08/28/2017
• 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; Required Intervention