MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT MEXICO SA NELLCOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number PEDICAP

Device Problems Labelling, Instructions for Use or Training Problem (1318); Use of Device Problem (1670); Human-Device Interface Problem (2949)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The report did not provide the lot number which determines the date of manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic was notified of an event through clinical literature publication regarding an infant with imperforate anus.Report stated the endotracheal intubation was "confirmed" by detection of exhaled carbon dioxide with a pedi-cap (covidien, (b)(4)) and subsequent chest x-ray.Further investigation of the event revealed a false positive of bronchial placement due to patient intubation within the esophagus.Investigation efforts are ongoing regarding the circumstances of the reported event.

Manufacturer Narrative

Further investigation of the customer event revealed the product was not a contributory factor in the patient¿s death.A medical safety review of the patient event was completed and determined there is no current long term treatment available for this type of defect and while temporary management may include insertion of an esophageal tube, infants with a complete absence of the trachea tend to die within hours of birth, as a permanent airway cannot be created.The esophageal tube placement assisted in temporarily prolonging the life of the patient, just as mentioned in the mcgill j med.2011 jun; 13(1): 10.Published online 2011 jun., but would not be a permanent solution for survival of the patient.Per the ifu, correct positioning must be verified by clinical assessment and identification of carbon dioxide in the expired gas.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic was notified of an event through clinical literature publication regarding an infant with imperforate anus.Report stated the endotracheal intubation was "confirmed" by detection of exhaled carbon dioxide with a pedi-cap (covidien, (b)(4) and subsequent chest x-ray.Further investigation of the event revealed a false positive of bronchial placement due to patient intubation within the esophagus.

• Brand Name: NELLCOR
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana ; MX
• Manufacturer (Section G): NELLCOR PURITAN BENNETT MEXICO SA; boulevard insurgentes 19030; tijuana ; MX
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 6742112
• MDR Text Key: 80963925
• Report Number: 9610849-2017-05008
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PEDICAP
• Device Catalogue Number: PEDICAP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2017
• 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 Weight: 2