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

Catalog Number 21-7036-01

Device Problem Leak/Splash (1354)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

Voluntary medwatch submission #: mw5066842.The reporter noted that the event occurred "(b)(6) 2016 thru present" and "summer 2016".It was reported that (b)(6) 2016 was the earliest date of related reports.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® extension set was leaking at the cassette.The patient may have required additional treatment.It is unclear what the impact to the patient was.See mfr: 3012307300-2017-00383, 3012307300-2017-00384, 3012307300-2017-00385, 3012307300-2017-00386, 3012307300-2017-00387, 3012307300-2017-00388, 3012307300-2017-00389, 3012307300-2017-00390, 3012307300-2017-00391, 3012307300-2017-00392, 3012307300-2017-00393, 3012307300-2017-00394, 3012307300-2017-00395, 3012307300-2017-00396, 3012307300-2017-00397, 3012307300-2017-00398, 3012307300-2017-00399, 3012307300-2017-00400, 3012307300-2017-00401, 3012307300-2017-00402, and 3012307300-2017-00403.

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® EXTENSION 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: 6304379
• MDR Text Key: 66616491
• Report Number: 3012307300-2017-00392
• 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: 03/09/2017

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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2017
• 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; Other