MAUDE Adverse Event Report: COVIDIEN CURITY MONO-FLO 20FR WO PVPI; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	6158MF
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2020
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.
Event or Problem Description
The customer reported that the catheter came off of the tube of the bag during use.It appeared that the connection was loose.There was no patient harm.
Additional Manufacturer Narrative
Note - section d4 has been updated to include lot number: 1923317364 one decontaminated drainage bag with date code 238-9d61 and one 18 fr catheter were received at the manufacturing site on november 19, 2020 for evaluation.According to the date code 238-9d61, lot number 1923317364 was obtained.The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Visual and functional evaluations were performed, and the reported condition could not be confirmed; the sample received did not show the disassembly of the catheter and the pvc tube.The sample was found to be working according to quality specifications.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.We will continue to monitor the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: CURITY MONO-FLO 20FR WO PVPI
• Common Device Name: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10712366
• Report Number: 9612030-2020-02668
• Device Sequence Number: 3899263
• Product Code: KNX
• UDI-Device Identifier: 10884521050563
• UDI-Public: 10884521050563
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/05/2021

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: 6158MF
• Device Catalogue Number: 6158MF
• Device Lot Number: 1923317364
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 02/05/2021
• Patient Sequence Number: 1