MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,400X2D,P.ONLY,-,OQ,5; ELASTOMERIC LFR

Model Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the actual device was not returned.A review of the device history record (dhr) was not performed.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 (b)(4).

Event Description

Fill volume: 550 ml.Flow rate: 4 ml/hr procedure: laparoscopic low anterior resection, complete mobilization of splenic flexure, omental pedicle flap to the pelvis cathplace: right and left upper abdomen.A report was received stating a possible infection from a catheter.The procedure was performed on (b)(6) 2016.The catheter was removed on (b)(6) 2016 and the infection was diagnosed at that time.The pump was not emptied when removed.The pump was connected to the patient during the surgery procedure before skin closure.The patient presented with fever; right upper abdomen catheter site redness.The catheter site was hard to touch, painful, hot to touch.A laboratory culture was not done.The patient was treated with oral augmentin, 500nmg, two times daily for 7-days.The patient responded to the treatment well.The patient had no fever and had marked decrease in swelling, tenderness and redness within 3-days.The patient was improving daily with no lasting effects the fascia at the small midline surgical incision was closed with a running #1 stratafix pds suture.The wound was pulse lavaged with a total of one liter acitracin irrigation.The skin incision was closed with running subcuticular 4-0 monocryl and dermabond was applied.The on-q pain catheter was placed through the peel-away sheaths, each loaded with 5 ml of 0.5% marcaine without epinephrine.There was no implant for this surgery.The length of the procedure was 187 minutes.No drains were placed.Prophylaxis antibiotics were used per standard.The surgeon believes the infection was related to the use of the device.

• Brand Name: SURGPN,400X2D,P.ONLY,-,OQ,5
• 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: 5761784
• MDR Text Key: 48655360
• Report Number: 2026095-2016-00081
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/01/2016

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: Other Health Care Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2016
• Initial Date FDA Received: 06/30/2016
• 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
• Patient Weight: 92