MAUDE Adverse Event Report: MALLINCKRODT INC./ COVIDIEN MALLINCKRODT; SATIN-SLIP INTUBATING STYLET - 6 FR

Catalog Number 85863

Device Problems Break (1069); Detachment Of Device Component (1104); Physical Resistance (2578)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/23/2016

Event Type  Injury  

Event Description

Baby was intubated and when attempting to remove stylet, there was resistance and extra effort was required to remove stylet.Ventilation was performed by staff and arrangements for transfer to (b)(6) hospital in (b)(6), were made.Upon arrival of nicu team from (b)(6), baby was extubated at which time a small piece of plastic was seen in the baby's oral pharynx and was removed by mcgill forceps.At that time it was discovered that the intubation stylet's plastic sheath had broken, leaving part of the sheath in the baby.

• Brand Name: MALLINCKRODT
• Type of Device: SATIN-SLIP INTUBATING STYLET - 6 FR
• Manufacturer (Section D): MALLINCKRODT INC./ COVIDIEN; st. louis MO 6313
• MDR Report Key: 6157607
• MDR Text Key: 62137036
• Report Number: MW5066593
• Device Sequence Number: 1
• Product Code: BSR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 85863
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 3