MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,400X2-14,CB SAF,-,OQ,5; ELASTOMERIC - SAF

Model Number CB004

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Type  Injury  

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.(b)(4) 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 (b)(4) complaint database and identified as complaint (b)(4).Device not returned.

Event Description

Fill volume: unknown.Flow rate: unknown.Procedure: fem-pop bypass case.Cathplace: unknown.A report was received stating there was a post-operative wound infection.The patient had surgery 3-4 weeks ago with placement of on-q silver soaker catheters and pump.The hospital protocol course was standard, pump removed on post-operative day three.There was no evidence of infection until doctor's office visit (3-4 weeks post-operative).At the visit, the patient had a dehisced wound and the doctor stated he could see the catheter tract in the open wound and it was also infected.No additional information was provided.

• Brand Name: SURGPN,400X2-14,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, 22116 ; MX
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6031322
• MDR Text Key: 57553066
• Report Number: 2026095-2016-00164
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: CB004
• Device Catalogue Number: 101347200
• Device Lot Number: UNKNOWN
• Other Device ID Number: 10680651134728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2016
• Initial Date FDA Received: 10/14/2016
• 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 Outcome(s): Other