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	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2020
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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that during the balloon inspection, the water could not be removed from the balloon.
Additional Manufacturer Narrative
The following field has been corrected: section d4: the lot number provided with the complaint record was incorrect.The correct lot number is 1910653064.The device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One sample was received for the evaluation.Upon evaluation, the reported condition is confirmed.The component is produced by external supplier and the assembly process consists in a pick and place operation.There is no additional inspection on the line to detect the reported condition.A production notification was sent to all personnel to ensure that they are aware on the condition reported by the customer.The root cause and the corrective actions will be implemented and documented through the supplier notification 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: 9874556
• Report Number: 9612030-2020-02439
• Device Sequence Number: 3183174
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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
• Device Lot Number: 1910653064
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 05/26/2020
• Patient Sequence Number: 1