MAUDE Adverse Event Report: COVIDIEN LATX FR 14FR POVIDONE IOD 10OZ; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number	3450LF
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
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 while doing a straight catheter on a male patient, he noticed that part way through positioning the straight catheter, urine was flowing onto the padding they placed to protect the patient and bedding from spills.The catheter has separated where the blue portion of the tube and the white portions meet.It was reconnected and the health care provider (hcp) made sure there was no pulling from the weight of the urine bag but it separated again.The hcp compensated by making sure they held the connection securely until the bladder has been drained of urine and the catheter was removed.

• Brand Name: LATX FR 14FR POVIDONE IOD 10OZ
• Common Device Name: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8893639
• Report Number: 9612030-2019-02241
• Device Sequence Number: 1628114
• Product Code: FCM
• UDI-Device Identifier: 10884521009585
• UDI-Public: 10884521009585
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2019

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: 3450LF
• Device Catalogue Number: 3450LF
• Device Lot Number: 1908535364
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/14/2019
• Patient Sequence Number: 1