MAUDE Adverse Event Report: COVIDIEN 6208 URINARY DRAIN SET; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number 6208-

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation as it has been 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.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the plastic chamber connected to the bag does not allow liquid to pass through to the bag.The bag also leaks.There was no patient harm reported.

• Brand Name: 6208 URINARY DRAIN SET
• Type of Device: COLLECTOR, URINE, (AND ACCESSORIES) 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: 10941504
• MDR Text Key: 219379134
• Report Number: 9612030-2020-02702
• Device Sequence Number: 1
• Product Code: KNX
• UDI-Device Identifier: 10884521001916
• UDI-Public: 10884521001916
• 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: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6208-
• Device Catalogue Number: 6208-
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1