MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,270X2D,P.ONLY,-,OQ,5; ELASTOMERIC LFR

Model Number P270X4D

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: 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.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.(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

A report was received stating the patient had an infection after a total knee replacement surgery.The patient was re-hospitalized.The patient was diagnosed with infection during readmission.Additional information received on 16-mar-2016 stated the patient had a staphylococcus aureus infection at the knee wound.She was scheduled to undergo a washout procedure.The infection did not involve the knee joint, the infection was superficial.The healthcare provider did not make reference that the infection was related to the onq pump.Additional information received on 29-mar-2016 stated the patient called the nurse hotline and reported she was released from the hospital on(b)(6) 2016.The patient reported doing fairly well at the time of the call to the hotline nurse.The patient continued to have a low grade fever and her knee wound was oozing and draining.The patient was under the care of home health nurses.The patient was taking oral antibiotics.The patient had staples in her knee.The patient received intravenous vancomycin while in the hospital.The patient noted the doctors instructed her that the infection was caused by multiple factors and possibly by germs already existing inside the patient's body.

• Brand Name: SURGPN,270X2D,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: 5574774
• MDR Text Key: 42604988
• Report Number: 2026095-2016-00028
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2016

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?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: P270X4D
• Device Catalogue Number: 101367202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/13/2016
• 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
• Patient Age: 36 YR
• Patient Weight: 56