MAUDE Adverse Event Report: HALYARD - IRVINE UNKNOWN ACUTE PAIN CATHETER; CATHETERS

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

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.All information reasonably known as of 22-jun-2018 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.This product incident is documented in the halyard health 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.The device was not returned.

Event Description

Fill volume: unknown, flow rate: unknown, procedure: abdominoplasty, cathplace: incisional.A report was received stating that a catheter break incident occurred.Both catheters were removed.The nurse called the product support hotline and wanted know if the catheter would be visible on an x-ray.The nurse believed one catheter was not removed completely because it wasn't as long as other catheter on removal.Additional information received 31-may-2018 stated the patient was returning to the doctor's office on thursday and they were going to make a small incision to remove the rest of the catheter.Additional information received 08-jun-2018 noted the nurse stated that it was a very routine procedure to remove the catheter from the patient.The two catheters were placed incisionally for this patient.One catheter came out about 5-inches shorter than the other one, so the nurse knew it was broken inside of the patient.During removal, there was no resistance and nothing unusual for her to take both catheters out until the nurse saw one catheter was a lot shorter than the other.There was no x-ray performed on the patient.The broken piece in the patient was removed by the physician during an in-office visit the next day.The piece came out to be a foot long as the nurse estimated.The piece of the catheter was not saved.The patient was reported to be doing very well at that time.No additional information was provided.

• Brand Name: UNKNOWN ACUTE PAIN CATHETER
• Type of Device: CATHETERS
• 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: 7636200
• MDR Text Key: 112759196
• Report Number: 2026095-2018-00068
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• 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: N
• Patient Sequence Number: 1