MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,270X5,HMPMPC,-,LFR-CS,24; ELASTOMERIC LFR

Model Number C270050

Device Problem Infusion or Flow Problem (2964)

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); Toxicity (2333); Dysuria (2684)

Event Date 08/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the actual device was not returned.The device history record for the reported lot number, 0202195126, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation therefore, we are unable to determine the cause for the reported event.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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.

Event Description

Fill volume: 230 ml.Flow rate: 5 ml/hr.Procedure: unknown.Cathplace: unknown.Halyard received a single report that referenced 5 different incidences, which were associated with separate units, involving five different patients.This is the fifth of five reports.Refer to 2026095-2016-00171 for the first patient.Refer to 2026095-2016-00172 for the second patient.Refer to 2026095-2016-00173 for the third patient.Refer to 2026095-2016-00174 for the fourth patient.A report was received from (b)(6) stating there was a reported fast flow event.The infusion was prescribed for 46- hours but the patient could not state the end time, but only the period of the day.On (b)(6) 2016 the patient presented to the service intercurrence oncological center (caio) complaining of pain in the abdominal area, nausea, vomiting, non-palliate pain and dysuria.The patient was hospitalized on (b)(6) 2016 and was in the hospital until (b)(6) 2016, with a diagnosis of toxicity to chemotherapy and other reasons, paliado symptoms.The patent improved with intra venous (iv) medications and was discharged home with prescriptions.

• Brand Name: SURGPN,270X5,HMPMPC,-,LFR-CS,24
• 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. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6038421
• MDR Text Key: 57780698
• Report Number: 2026095-2016-00175
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: PK052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: C270050
• Device Catalogue Number: 101356802
• Device Lot Number: 0202195126
• Other Device ID Number: 30680651348839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• 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
• Treatment: 5FU
• Patient Outcome(s): Hospitalization