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 Clinical Signs, Symptoms or Conditions (4582)
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 respiratory department reported the therapist tried 3 separate suction catheters and none would suction.She thinks there may have been a slit or hole in the line.There was no patient harm.

• 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: 11057481
• Report Number: 9612030-2020-02729
• Device Sequence Number: 19504004
• Product Code: JOL
• UDI-Device Identifier: 10884527002412
• UDI-Public: 10884527002412
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/22/2020

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: 2014711564
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/22/2020
• Patient Sequence Number: 1