MAUDE Adverse Event Report: COVIDIEN FRANCE PRC ADV 18FR L UL F TY; URINARY DRAINAGE COLLECTION KIT, FOR INDWELLING CATHETER

Model Number	FPP18UL
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 the catheter detached from the tubing that leads to the bag and was found to be leaking when the diaper was changed.There was no patient harm.

• Brand Name: FRANCE PRC ADV 18FR L UL F TY
• Common Device Name: URINARY DRAINAGE COLLECTION KIT, FOR INDWELLING CATHETER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11029520
• Report Number: 9612030-2020-02723
• Device Sequence Number: 16817431
• Product Code: FCN
• UDI-Device Identifier: 10884521046733
• UDI-Public: 10884521046733
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

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: FPP18UL
• Device Catalogue Number: FPP18UL
• Device Lot Number: 1912802064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 12/17/2020
• Patient Sequence Number: 1