MAUDE Adverse Event Report: HALYARD - IRVINE UNKNOWN; CATHETER

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problems Cellulitis (1768); Unspecified Infection (1930)

Event Date 05/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.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: unknown.Flow rate: unknown.Procedure: myomectomy.Cathplace: under the fascia and in the subcutaneous layer.A report was received stating in (b)(6) 2015 there were two catheter break incidents in which a dual on-q pump was used.One catheter was successfully removed and the other broke inside of the patient.Additional information received 13-jul-2016 stated initially the bupivacaine pain catheter was sutured "under the fascia and in the subcutaneous layer." on (b)(6) 2015 the patient was admitted for infection and cellulitis due to retained catheter.On (b)(6) 2015 it was later discovered by the physician that the catheter was sutured to the fascia layer instead and thus was unable to be remove.On (b)(6) 2016 a surgical wound exploration was required for removal of retained catheter.On 21-jul-2016 additional information from the physician stated the product was not an issue.The issue was due to user error.In addition, the patient was more susceptible to infection because she suffers from an autoimmune disease.No additional information was provided.

• Brand Name: UNKNOWN
• Type of Device: CATHETER
• 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: 5846251
• MDR Text Key: 52407323
• Report Number: 2026095-2016-00108
• Device Sequence Number: 1
• Product Code: BSO
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2016

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
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 54