MAUDE Adverse Event Report: CONVATEC INC TRIO; PROTECTOR, OSTOMY

Model Number 423282

Device Problems Fire (1245); Off-Label Use (1494); Flare or Flash (2942)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Type  malfunction  

Event Description

The distributor that during a cardiovascular surgery in pediatrics at a known hospital, on a one-year-old girl, the doctors applied company's known remover spray to remove the antimicrobial incise drape.The skin was washed with microbicidal skin cleaner solution and subsequently washed and debrided the external wound and then applied company's known skin protector in a wet towel presentation with the aim of applying the new antimicrobial incise drape adhesive tape.The surgery resident identified a suture that was bleeding and proceeded to turn on the electro-scalpel to correct the bleeding.A flame was immediately generated in the pediatric intensive care unit (icu) cubicle where they were performed the procedure.The surgical fields were burned, the foam from the negative pressure system that was covering the wound bed and as an immediate reaction, the surgery resident picked up the surgical fields that were on fire covering the girl, to prevent her from burning.At the time of the fire, the open sternotomy and the wound bed were covered by two foams: a white foam in direct contact with the heart and on top of it a black foam from the negative pressure system.Apparently, no burns were caused to the medical and nursing staff (children's cardiovascular surgeon, cardiovascular surgery resident, surgical instrument technician and nursing assistant) who were present at the time of the incident nor to the medical teams, but the institution will verify further in detail the status of the equipment and personnel.The institution's engineering team verified whether the fire was caused by a leak, but they found no leaks in either the cubicle or the pediatric intensive care unit (icu) service.The girl had a grade ii skin burn.A photograph depicting the issue was received from the complainant.

Manufacturer Narrative

E1: complainant city: (b)(6) complainant state: (b)(6) complainant country: colombia name of affiliation: (b)(6) name of hospital: (b)(6)patient city: (b)(6).Patient state/province: antioquía a2: age at time of event - 1 year brand name of antimicrobial incise drape: ioban brand name of microbicidal skin cleaner solution : prepodyne.The device has malfunctioned and would be likely to cause or contribute to a death or serious injury if it were to recur.Based on the circumstances of the reported complaint, the case has been submitted as a reportable malfunction and there was minor harm experienced, and it has been reported under imdrf health impact code and clinical code.Based on the available information, this event is deemed to be a reportable malfunction.A review of the ifu by the convatec clinical team indicated noted the flammable warnings are included on the product and the product packaging has the necessary warning symbols to highlight this.The ifu also includes warnings to keep away from ignition sources and sparks.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 third party manufacturing site: 3010605379.

Manufacturer Narrative

Correction (d5): the incorrect operator of device was submitted along with initial emdr (b)(4) with mfg report number: 1049092-2024-00024 on 03/15/2024.However, the correct operator of device for initial emdr should be health professional.Please disregard the previous one.Additional information - this emdr is being submitted to include the below information: describe event or problem (b5): it was mentioned that the patient was unfortunately died, however the cause of death and date of death is unknown.To date there has been no further communication with the clinic nor have they or the family members made a formal claim to company.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092; third party manufacturing site: 3010605379.

Event Description

To date, additional patient or event details were received which have been added in h11 (addl mfg narrative).

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions h11: investigation summary: supplier investigated and found out that no issues were reported during the manufacturing period of lot t3163 with a total of (b)(4) being produced on purchase order (po) no: (b)(4).The coa (certificate of authenticity) is attached to child record in database.Conformance statement: 1.Quality assurance officer (qao) confirmed that qao issued and hold in confidence the tp product specification 2.All raw materials, formulation and bulk blending processes conform to the tp product specification.3.Supplier documentation, inspection and test records to assurance conformance to the specification are on file and may be examined upon request.This investigation will be closed.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number.Reporting site: 1049092.Third party manufacturing site: 3010605379.

• Brand Name: TRIO
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 18911672
• MDR Text Key: 337740795
• Report Number: 1049092-2024-00024
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 423282
• Device Lot Number: T3163
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female