MAUDE Adverse Event Report: COVIDIEN SAF VAC 6 FR 2 LF GL CUP KIT; CATHETER AND TIP, SUCTION

Model Number	36626
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that there was a blockage somewhere in the catheter which makes it unable to be used.This has occurred in many for lot number 1908413364.Additional information provided by the nicu manager stated that the issue was discovered while preparing to suction the patient.The catheter was unable to suction the patient.They confirmed that the patient was not harmed by this incident.

• Brand Name: SAF VAC 6 FR 2 LF GL CUP KIT
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9350234
• Report Number: 9612030-2019-02356
• Device Sequence Number: 2606790
• Product Code: JOL
• UDI-Device Identifier: 10884527002412
• UDI-Public: 10884527002412
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2019

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: 36626
• Device Catalogue Number: 36626
• Device Lot Number: 1908413364
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/20/2019
• Patient Sequence Number: 1
• Patient Age: 2 WK