MAUDE Adverse Event Report: COVIDIEN FOLY CATH 100 SLCON 5CC 16FR; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number	8887605163
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated no information about the sample return; 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 connector site to the urinary bag is loose and the tube of the bag comes out of its place very often.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One unused representative sample was received for evaluation.A visual inspection was performed with no issues found.The sample was inspected, and a deflation test was performed and no issues were identified.A further inspection was completed on the manufacturing in-line where the sample was inflated with 10ml of sterile water and the unit was placed in a heated water bath set to 37 degrees celcius to replicate normal operating conditions for a period of 24 hours.After the 24-hour period, the device was inspected, and the catheter remained inflated as required.There were no issues identified with the catheter.A root cause could not be identified; therefore, a corrective action is not deemed necessary at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: FOLY CATH 100 SLCON 5CC 16FR
• Common Device Name: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 10729360
• Report Number: 9611018-2020-00453
• Device Sequence Number: 16980638
• Product Code: FCM
• UDI-Device Identifier: 10884521016675
• UDI-Public: 10884521016675
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• 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,Followup
• Report Date (Section B): 03/03/2021

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: 8887605163
• Device Catalogue Number: 8887605163
• Device Lot Number: 18J284FHX
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 03/03/2021
• Patient Sequence Number: 1