MAUDE Adverse Event Report: MALLINCKRODT MEDICAL MALLINCKRODT; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	110870
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, the patient was intubated and the depth of the tube was adjusted.The customer reported that air leak from the cuff was observed.
Additional Manufacturer Narrative
Evaluation summary: one sample was returned for evaluation.An attempt made to inflate the returned unit, however, the cuff failed to inflate.Examination of the cuff body using the microvu shows that there is a ¿v¿ shaped slit in the main body of the cuff.The slit is clean cut measuring 0.9mm x 1.5mm in length.This type of damage is indicative of contact with a sharp utensil or object.The single wall thickness of the cuff was measured and found to be within the blueprint print specifications.The most probable root cause is the cuff body came in contact with a sharp utensil or object.All of our endotracheal products undergo a four hour inflate/deflate test and it is at this stage of the process that any defects are removed from the lot.The unit returned for evaluation would not have passed this inspection.Instructions for use(ifu) warnings / precautions (cuff-related) states ¿various bony anatomical structures (e.G.Teeth, turbinates) within the intubation routes or any intubation tools with sharp surfaces present a threat to maintaining cuff integrity.Care should be taken to avoid damaging the ultrathin-walled cuff during insertion, subjecting the patient to reinsertion of another device¿.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: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 7592644
• Report Number: 8020889-2018-00058
• Device Sequence Number: 11298674
• Product Code: BTR
• UDI-Device Identifier: 20884521068213
• UDI-Public: 20884521068213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: 110870
• Device Catalogue Number: 110870
• Device Lot Number: 201611618X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention