MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE

Model Number 125137

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the device had missing components and could not be used.There was no patient injury.No other information was provided.

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.The reported defect could be detected.These three unit packs are joined together by a tear away seal.Assemblies or the original unit carton was not returned.The reported defect could be detected.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• Type of Device: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 7876784
• MDR Text Key: 120307334
• Report Number: 8020889-2018-00084
• Device Sequence Number: 1
• Product Code: BYE
• UDI-Device Identifier: 30884522008697
• UDI-Public: 30884522008697
• Combination Product (y/n): N
• PMA/PMN Number: K912240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 125137
• Device Catalogue Number: 125137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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