MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	60XLTCP
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	Extubate (2402)
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, two trach tubes were leaking and unable to maintain air in the balloon.The customer reported that there was no known patient involvement and outcome.
Additional Manufacturer Narrative
Evaluation summary: one sample was returned for evaluation.Visual examination confirms that the returned unit is contaminated.The returned unit was inflated, however, the air deflated rapidly from the cuff body.Further examination of the cuff body using the microvu shows that there is a slit in the main body of the cuff.The slit is clean cut in appearance measuring 0.4mm in length.This type of damage is indicative of coming in contact with a sharp utensil or object.The reported defect could be detected on this sample.The single wall thickness of the cuff was measured away from the damaged area and found to be within the blueprint specification.The batch paperwork was reviewed and confirms that the lot was manufactured to meet all of the blueprint specifications and quality requirements.Four samples were returned for evaluation and all contained in their original unopened unit packs.Visual examination shows no sign of any defect.All four units were inflated and leak tested under water.No leakage was detected.The returned units remained inflated for a four-hour period and no leakages were detected.The reported defect could not be detected on the units returned for evaluation.The most probable root cause of the damage to the contaminated sample is it came in contact with a sharp utensil or object.The product relates to the reported complaint event.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
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 7468811
• Report Number: 8020889-2018-00049
• Device Sequence Number: 1052079
• Product Code: JOH
• UDI-Device Identifier: 20884522028162
• UDI-Public: 20884522028162
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K051416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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: 11/01/2022
• Device Model Number: 60XLTCP
• Device Catalogue Number: 60XLTCP
• Device Lot Number: 201711083X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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