MAUDE Adverse Event Report: COVIDIEN CURITY MONO-FLO 14FR WO PVPI; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	6162MF
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	04/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Facility name should reflect "(b)(6) hospital (b)(6) hospital" but not all characters fit in that field.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 detached from the tube at the connecting part.
Additional Manufacturer Narrative
A device history record could not be reviewed because a lot number could not be provided by the customer.However, all record from manufacturing lots were reviewed and ensure that products were released meeting all quality release specifications at the time of manufacture.One sample was received for evaluation.An analysis of the returned sample determined that the catheter was detached from the tube at the connection.The reported condition has been confirmed.The potential root cause is due to a miss-alignment of the equipment used during the manufacturing process for the pvc tubing.The action plan will be to install monitoring equipment into the extruder to measure the outer diameter during the extrusion process.

• Brand Name: CURITY MONO-FLO 14FR 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: 10005910
• Report Number: 9612030-2020-02457
• Device Sequence Number: 2897646
• Product Code: KNX
• UDI-Device Identifier: 10884521050587
• UDI-Public: 10884521050587
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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: 6162MF
• Device Catalogue Number: 6162MF
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 08/11/2020
• Patient Sequence Number: 1