MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,600X2-14,CB SAF,-,OQ,5; ELASTOMERIC - SAF

Model Number CB6004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); Irritation (1941); Rash (2033); Swelling (2091); No Code Available (3191)

Event Date 12/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.Root cause could not be determined.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).

Event Description

Procedure: manipulation of elbow.A caregiver reported that she removed the patient¿s pump because of irritation to the area.At that time, the pump was only half empty.The area around the dressing was red, swollen, "rashy", and warm to the touch.The caregiver stated that there was greenish pus-like drainage on the end of the catheter, and there was an odor to it.Currently, there is clear drainage coming from the insertion site.The patient¿s temperature was noted as 102 degrees.No further information was provided.

Manufacturer Narrative

All information reasonably known as of 22-may-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.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).

Event Description

Additional information received stated that the surgeon did not provide any additional information regarding the reported signs or symptoms, with no associated diagnosis.The catheter was located in the patient's upper arm, and after approximately 12 hours after removal, the patient began to feel better and the swelling subsided.It was assumed that the patient must have had a reaction to the catheter.It was noted that the catheter had a round disc and a very thin line.No further information was provided.

• Brand Name: SURGPN,600X2-14,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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6228204
• MDR Text Key: 64021440
• Report Number: 2026095-2017-00002
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651134760
• UDI-Public: 30680651134760
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2018
• Device Model Number: CB6004
• Device Catalogue Number: 101347602
• Device Lot Number: 0202466310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 79