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 Codes	Pain (1994); Urinary Retention (2119)
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 that the catheter failed approximately 2 weeks after insertion.They speculate there was an accumulation of residue resulting in blockage and possible infection.The resident had a full bladder and pain and when a new foley catheter was inserted she had upwards of 900cc of urine in her bladder.Additionally, the silver lined catheters are difficult to flush when they block.

• 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: 11171296
• Report Number: 9612030-2021-02750
• Device Sequence Number: 2766503
• 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): 01/14/2021

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: 01/14/2021
• Patient Sequence Number: 1