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

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

Voluntary medwatch submission #: mw5066816.Potential catalog number: (b)(4).Potential lot number: 46x824.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 a "device defect".It was unclear what the impact to the patient was.

Manufacturer Narrative

Additional information was received that detailed that this incident had been captured previously.The following is a list of reported mfrs related to this mdr: 3012307300-2017-00404, 3012307300-2017-00405, 3012307300-2017-00406, 3012307300-2017-00407, 3012307300-2017-00408, 3012307300-2017-00409, 3012307300-2017-00410, 3012307300-2017-00411, 3012307300-2017-00412, 3012307300-2017-00413, 3012307300-2017-00414, 3012307300-2017-00415, 3012307300-2017-00416, 3012307300-2017-00417, 3012307300-2017-00418, 3012307300-2017-00419, 3012307300-2017-00421, 3012307300-2017-00422, 3012307300-2017-00423, 3012307300-2017-00659, 3012307300-2017-00660, 3012307300-2017-00661, 3012307300-2017-00662, 3012307300-2017-00663, 3012307300-2017-00664, and 3012307300-2017-00665.Upon further review, this file is considered a duplicate and it is not considered a reportable event at this time.

• 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: 6304677
• MDR Text Key: 66616878
• Report Number: 3012307300-2017-00424
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 04/03/2017

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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability