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 Patient Involvement (2645)
Date of Event	12/17/2019
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.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 the water was unable to be removed from the balloon.The issue occurred prior to patient use during testing.
Additional Manufacturer Narrative
H 3 evaluation summary: the device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and quality documentation.One decontaminated catheter was received for evaluation.A functional inspection was performed showing the sample received complied with manufacturing specifications.The balloon was able to be deflated within the acceptable specified range.The reported condition could not be confirmed.No formal investigation action is required because the results of the product¿s analysis was acceptable.Corrective action will be limited to supplier awareness.This complaint will be used 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: 9506372
• Report Number: 9612030-2019-02380
• Device Sequence Number: 16665511
• 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
• Device Lot Number: 1909314664
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 02/14/2020
• Patient Sequence Number: 1