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

Model Number	8944MF
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2019
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 balloon was unable to deflate during inspection.
Additional Manufacturer Narrative
A review of the device history record could not be conducted because a lot number was not provided.One decontaminated catheter labeled with lot 36218-071 was received for evaluation.A functional inspection was performed with acceptable results; the physical sample was tested as per specification.Any catheter that does not deflate in 15 minutes is considered a non-deflator; the sample received does comply with this specification.The balloon deflated in 16.47 sec.No formal investigation action is required due to the product¿s analysis in which the catheter was tested with acceptable results.The reported condition cannot be confirmed.Corrective action will be limited to the supplier awareness.This complaint will be recorded for tracking and trending purposes.

• Brand Name: CURITY ANT-REF 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: 9558429
• Report Number: 9612030-2020-02386
• Device Sequence Number: 2314262
• Product Code: KNX
• UDI-Device Identifier: 10884521050648
• UDI-Public: 10884521050648
• 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): 02/14/2020

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: 8944MF
• Device Catalogue Number: 8944MF
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/14/2020
• Patient Sequence Number: 1