MAUDE Adverse Event Report: COVIDIEN DOVER SLVR FOLEY CATH18FR5CC2W; CATHETER, RETENTION TYPE, BALLOON

Model Number 605189IC

Device Problem Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2020

Event Type  malfunction  

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 Description

The customer reported that the catheter failed to last one month.There was an accumulation of residue resulting in blockage and possible infection.

Manufacturer Narrative

Section b5 has been updated to include the following additional information provided by the customer: additional information provided by the customer on december 30, 2020, stated that the catheter plugged approximately two weeks after insertion.When the catheter was removed, they could not see inside of the catheter therefor is it unknown if sediment was building up, this is speculation only.Additionally, when the silver lined catheters block, it is impossible to flush them, they simply block which requires more frequent changes.No further specific information is available at this time.

Event Description

The customer reported that the catheter failed to last one month.There was an accumulation of residue resulting in blockage and possible infection.Additional information provided by the customer on december 30, 2020, stated that the catheter plugged approximately two weeks after insertion.When the catheter was removed, they could not see inside of the catheter therefor is it unknown if sediment was building up, this is speculation only.Additionally, when the silver lined catheters block, it is impossible to flush them, they simply block which requires more frequent changes.No further specific information is available at this time.

• Brand Name: DOVER SLVR FOLEY CATH18FR5CC2W
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11018850
• MDR Text Key: 221740868
• Report Number: 9612030-2020-02720
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 10884521026469
• UDI-Public: 10884521026469
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

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
• Device Operator: No Information
• Device Model Number: 605189IC
• Device Catalogue Number: 605189IC
• Device Lot Number: 1819708064
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 12/07/2020
• Supplement Dates FDA Received: 01/11/2021
• Patient Sequence Number: 1