MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,400X2-14,CB SAF,-,OQ,5; ELASTOMERIC - SAF

Model Number K063530

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

(b)(4).Udi # unknown.Method: the actual device was not returned.A lot number was not provided and review of the device history record (dhr) was not performed.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to (b)(4) for evaluation therefore, we are unable to determine the cause for the reported event.(b)(4) has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the (b)(4) complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a (b)(4) product is defective or caused serious injury.Device not returned.

Event Description

Fill volume: unknown; flow rate: unknown; procedure: unknown; cathplace: interscalene block.A report was received stating an anesthesiologist notified a company representative of a death that occurred with a patient on post-op day one.The patient had an on-q pump.The anesthesiologist stated the patient had a lot of co-morbidities and believed that the on-q pump did not have anything to do with the incident of death.Additional information received on 18-may-2016 stated the nurse was performing a routine post-op follow-up call to the patient.This nurse was notified that the patient passed away while sleeping during the night.No additional information was provided.

• Brand Name: SURGPN,400X2-14,CB SAF,-,OQ,5
• Type of Device: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana, b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5686256
• MDR Text Key: 46162308
• Report Number: 2026095-2016-00053
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: K063530
• Device Catalogue Number: 101347200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death