MAUDE Adverse Event Report: COVIDIEN IRRIG TRAY W/PISTON SYRINGE; SYRINGE, IRRIGATING (NON DENTAL)

Model Number	68800
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the large 60cc syringe does create enough suction to pull out and measure the stomach contents of patients.It gives a false sense that there is no residual, when actually the patient has a large residual.A patient was overfed and aspirated during the time residuals were marked as zero.It was suspected by the customer but not confirmed that it was related to high residuals and continued feeding of the patient.The patient involved had multiple co-morbidities and was eventually terminally extubated and given comfort care.The customer stated the family¿s decision was not related to the aspiration.

• Brand Name: IRRIG TRAY W/PISTON SYRINGE
• Common Device Name: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9494803
• Report Number: 9612030-2019-02378
• Device Sequence Number: 3675389
• Product Code: KYZ
• UDI-Device Identifier: 10884521008236
• UDI-Public: 10884521008236
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 68800
• Device Catalogue Number: 68800
• Device Lot Number: 1924623064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/19/2019
• Patient Sequence Number: 1