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

Model Number	605189IC
Medical Device Problem Code	Obstruction of Flow (2423)
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 customer reported the catheters fail to last one month and accumulation of residue results in blockage and possible infection.Additional information from the customer stated the catheters are plugging approximately 2 weeks after insertion.When the catheters are removed they cannot see inside the catheter therefore it is unknown if sediment is building up; this is speculation only.Also, when the catheter blocks it is impossible to flush them requiring more frequent changes.

• Brand Name: DOVER SLVR FOLEY CATH18FR5CC2W
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11155964
• Report Number: 9612030-2021-02746
• Device Sequence Number: 767361
• Product Code: EZL
• UDI-Device Identifier: 10884521026469
• UDI-Public: 10884521026469
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/12/2021

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
• Operator of Device: No Information
• Device Model Number: 605189IC
• Device Catalogue Number: 605189IC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/12/2021
• Patient Sequence Number: 1