MAUDE Adverse Event Report: HALYARD - IRVINE UNKNOWN

Model Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problem Cellulitis (1768)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi # unknown.The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.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

Fill volume: unknown, flow rate: unknown, procedure: hernia repair, cathplace: unknown.A report was received stating the onq pain pump did not release the medication as indicated, it was actually causing the area to hurt because of too much fluid.The patient pulled it out after 36-hours as fluid streamed out of the opening before he could get a band aid to cover.The pain the patient received in the area was related to the ball pushing too much medication fluid at one time.Additional information received 30-jun-2016 the patient reported the incident occurred 6-years ago when the patient underwent an inguinal hernia and umbilical hernia repair at the same time.The patient was given an onq pain pump at the surgery site for pain management.It was supposed to last for 48-hours.The patient reported the pump emptied after about 24-hours.The patient noticed severe swelling at the catheter insertion area and had pain that felt like cellulitis.The patient removed the catheter after 36-hours, there was copious amount of clear liquid which came out of the catheter insertion site that the band-aid could not stay on.After about one and one-half hours, the swelling went done and the site was dry enough to keep a band-aid on.The cellulitis also subsided.The patient stated he had reported this incident to his surgeon and returned the pump to the surgeon.The patient said he would contact the manufacturer only recently because his chiropractor recently underwent a surgery without a pain management pump but instead used narcotics.The patient thought a pain management pump could have greatly benefited his chiropractor's situation.The patient then remembered to follow-up with his incident 6 years ago.No additional information was provided.

Manufacturer Narrative

Halyard health's complaint database identification number was incorrectly filed in the initial medwatch as complaint (b)(4).The correct halyard health complaint database identification number is complaint (b)(4).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).

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• 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: 5830732
• MDR Text Key: 51496168
• Report Number: 2026095-2016-00101
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 09/14/2016

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 Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2016
• 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: Initial
• Patient Sequence Number: 1