MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,OQ,P.ONLY,-,400X8,5; ELASTOMERIC LFR

Model Number P400X8

Device Problem Infusion or Flow Problem (2964)

Patient Problems Headache (1880); Rash (2033); Toxicity (2333)

Event Date 06/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi # unknown.The actual complaint product was not returned for evaluation.The device history record for the reported lot number, 103761200, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.(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 halyard health product is defective or caused serious injury.Device not returned.

Event Description

Fill volume: 550 ml; flow rate: 8 ml/hr; procedure: right subaccromial decompression and right rotatorcuff repair; cathplace: interscalene block.A report was received stating the patient experienced restlessness, red/rash on cheeks and face, headache, and a cough with no further reported injury and no needed medical intervention during an infusion with use of an on-q pump.The symptoms occurred 10-hours after surgery.The patient attempted to resolve the symptoms by using sinus spray.The device was clamped.The symptoms dissipated with the exception of a headache after the tubing was clamped for more than 2-hours.No additional information was provided.

Manufacturer Narrative

Corrected data: age.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).

• Brand Name: SURGPN,OQ,P.ONLY,-,400X8,5
• Type of Device: ELASTOMERIC LFR
• 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5766210
• MDR Text Key: 49390652
• Report Number: 2026095-2016-00084
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Model Number: P400X8
• Device Catalogue Number: 103761200
• Device Lot Number: 0202341885
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2016
• Initial Date FDA Received: 07/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 75