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	10/23/2020
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 the balloon is unable to deflate.The issue was found before use.
Additional Manufacturer Narrative
One unused sample with lot number 1913448464 was received for evaluation.The visual inspection was performed according to procedure however, based on the visual and functional evaluation, the issue reported by the customer was not confirmed as balloon was able to deflate; water came our normally.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the defect described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The condition reported by the customer was not confirmed.No conditions were found in the sample received.The sample were found to perform according to quality specifications.Based on the available information, confirmed, an action plan is not considered necessary as the sample received are within specification.We will continue to monitor the process for any adverse trends that require immediate attention.

• 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: 10741858
• Report Number: 9612030-2020-02678
• Device Sequence Number: 3335800
• 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): 02/11/2021

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: 8944MF
• Device Catalogue Number: 8944MF
• Device Lot Number: 1913448464
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 02/11/2021
• Patient Sequence Number: 1