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

Catalog Number 21-7036-01

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 10/20/2016

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 broken at the cassette and fluid was dripping at the point of entry to the cassette from the medication bag.Due to the incident, the patient missed one dose of medication.It was unclear what the impact to the patient was.See mfr: 3012307300-2017-00422.

Manufacturer Narrative

The customer reported that two devices contributed to two reported events (one device per event).The customer returned one device for evaluation.It could not be determined which reported occurrence was associated with the returned device; therefore, the evaluation of the one returned device will be used for the medwatch.One cadd® blue striped administration set was returned for investigation.The returned sample was received inside a plastic bag and without its original packaging.Visual inspection of the returned sample was conducted at a distance of 12" to 24" and under normal conditions of illumination.During visual inspection, it was found that the sample 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.Investigation determined that the root cause of the observed issue was due to manufacturing.

• 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: 6304667
• MDR Text Key: 66616294
• Report Number: 3012307300-2017-00421
• 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: 03/13/2017

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: 11/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2017
• 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