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

Model Number 68800

Device Problem Decrease in Suction (1146)

Patient Problem Aspiration/Inhalation (1725)

Event Type  malfunction  

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 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
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 9494803
• MDR Text Key: 177362107
• Report Number: 9612030-2019-02378
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 10884521008236
• UDI-Public: 10884521008236
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 68800
• Device Catalogue Number: 68800
• Device Lot Number: 1924623064
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1