MAUDE Adverse Event Report: COVIDIEN P400 UM 16FR SIL COUDE CSD IFC; URINARY DRAINAGE COLLECTION KIT, FOR INDWELLING CATHETER

Model Number P4P16CSDK

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation as it was discarded; 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 Description

The customer reported that the foley catheter was disconnected easily.The green seal remained intact but the foley was disconnecting where it connects to the tubing by the sample port.There was no patient involvement.

• Brand Name: P400 UM 16FR SIL COUDE CSD IFC
• Type of Device: URINARY DRAINAGE COLLECTION KIT, FOR INDWELLING CATHETER
• 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: 10098375
• MDR Text Key: 194376998
• Report Number: 9612030-2020-02478
• Device Sequence Number: 1
• Product Code: FCN
• UDI-Device Identifier: 10884521174061
• UDI-Public: 10884521174061
• 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: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P4P16CSDK
• Device Catalogue Number: P4P16CSDK
• Device Lot Number: 2001412064
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1